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Job DescriptionDescription: About the Company As a life science company and a leading supplier to global research markets, we offer a comprehensive product portfolio along with outstanding hands-on customer service to ensure every laboratory has the tools and support they need. Our markets include pharmaceutical and biotechnology businesses, research institutions, hospitals, reference labs, and more. Be part of making a difference At Genesee, we believe we can help improve our communities and transform the world through science. Our shared desire to make a difference is what drives and inspires us. We are a fast-growing, dynamic team that listens to each other and embraces collaboration. We foster an open, friendly work environment and show up for one another every day. Role: Sr. Warehouse Associate Reports to: Director, Distribution & Logistics FLSA: Non-Exempt Location: El Cajon, CA Why is this role important at Genesee Scientific? We are looking for enthusiastic, dependable team members who are committed to making a positive impact for our customers and colleagues every day. In this role, you will play a key part in ensuring quality products are delivered accurately and on time, while contributing to an efficient and supportive work environment. What will you do: • Assist in training and mentoring new associates, promoting best practices and ensuring adherence to operational standards, • Contribute to the creation of Standard Operating Procedures and/or Work Instructions, • Process customer orders daily to meet customer expectations efficiently and accurately, • Assist with proper storage and organization of products, • Assist with inventory audits/cycle counts to maintain accurate inventory records, • Ensure all products are packaged and labeled correctly according to standard operating procedures, including completing necessary documentation for hazardous materials, • Maintain compliance with safety protocols, actively promoting a safe working environment for all team members, • Collaborate with team members to resolve issues and enhance productivity, ensuring a positive work experience for everyone, • Identify areas for process improvement, root cause issues, and participate in initiatives to enhance warehouse operations and efficiency, • Hazardous materials (HazMat) certification or willingness to obtain (training provided), • Complete local delivery routes as needed, including loading products, safely operating a delivery vehicle, delivering packages up to 60lbs, and interacting with customers in a professional manner while complying with all transportation laws and regulations, • Operate Powered Industrial Truck (PIT) equipment as needed to move, stage, load, and unload materials., • Communicate professionally and effectively with peers and direct leadership Requirements: What you will bring: • 3+ years of relevant experience in a stockroom or warehouse is required, • Forklift certification is highly preferred; willingness to obtain certification if not currently held, • Familiarity with FedEx and UPS shipping programs is a plus, • Strong attention to detail and accuracy, • Excellent communication skills to coordinate with team members and other departments effectively, • Commitment to adhering to all safety protocols and maintaining a safe working environment, • Basic proficiency with computers and scanning equipment preferred, familiarity in Microsoft Office Suite applications including Teams, • Desire to work as part of a team, but also able to work independently and solve problems quickly, • Thrives in a fast-paced, collaborative environment. Works efficiently within deadlines Physical Requirements: Perform the following tasks, with or without reasonable accommodation: • Frequently lift and carry packages weighing up to 60 lbs., • Ability to operate a forklift, clamp devise, pallet jack, overhead crane devise and maintain OSHA forklift certification, • Walk up and down stairs and stand for extended periods throughout the shift, • Frequently bend and stoop to pick up packages, • Safely and efficiently operate a large delivery van, • Must be comfortable driving and working in varying weather conditions, • Adhere to assigned delivery routes and follow time schedules, • Efficiently pick, pack, and prepare items for shipment, • The role primarily requires prolonged standing and continuous movement throughout the work shift At Genesee Scientific, you can have a good job that can grow into a great career. We offer: • Training and professional growth initiatives, including comprehensive onboarding programs for new team members, • We provide financial well-being with competitive compensation packages and 401 (k) retirement savings plans, • Health care and well-being programs including medical, dental, vision, life, short- and long-term disability and employee assistance program, • Paid time off including vacation, sick and 12 holidays Candidates must be legally authorized to work in the United States without the need for current or future employer sponsorship. Employment offers are subject to successful completion of a background check and pre-employment drug test. Genesee Scientific is proud to be an Equal Employment Opportunity employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

Job DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. ESSENTIAL FUNCTIONS: (List specific duties and responsibilities) • Ensures the creation, revision, and enforcement of all aspects of MENTOR and the assigned client facilities Quality Management System (QMS), or in situations where MENTOR operates within the client's QMS, facilitates the integration and ongoing oversight aspects required by that QMS., • Lead the events & root cause analysis processes., • Oversight of the training programs and lead the inspection readiness programs, and vendor management programs., • Lead the review and administration of quality service level agreement (SLA) and Quality Management Systems as it pertains to quality and compliance requirements., • Also, will be responsible for the development and implementation of a strategy to ensure the client requirements are met, • Will travel to support MTG clients and operations as required EDUCATIONAL or EQUIVALENT REQUIREMENTS: (Minimum required to perform the job) • Bachelor's degree is required; Sciences or Engineering is preferred., • Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry., • Previous experience leading teams or projects., • Requires strong technical writing skills (English and Spanish)., • Ability to effectively read, write and verbally communicate in English and Spanish., • Computer literacy with MS Office applications (Word, Excel, Power Point, Outlook) and Quality Management Systems (e.g. Trackwise)., • Above average organizing, analyzing and a minimum of math (practical application of fractions, percentages, ratios, proportions, basic algebra) to determine organizational, Customer and regulatory problems and formulate corrective action plans., • Ability to adapt to changing responsibilities., • Requires effective interpersonal skills as demonstrated through prior experience., • Ability to work independently under minimal guidelines and supervision., • Working knowledge of applicable regulations and standards, including, but not limited to, GMP, GDP regulations and ISO standards., • Ability to motivate, train and develop staff within the MENTOR’s team., • Willingness to demonstrate through daily activities a model of continuous monitoring of quality system activities to ensure compliance with documented standards., • Demonstrated ability to analyze data and performance metrics., • Demonstrate decision making capabilities. RESPONSABILITIES: • Responsible for establishing objectives, mentoring direct and reports and managing resources to ensure successful execution of the Quality Management System., • Provide support for design, execution and maintenance of quality system processes at respective departments., • Help department to coordinate training to operating procedure changes or new system implementation., • Recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance department effectiveness., • Lead the implementation and maintenance of quality systems, including data analysis to identify opportunities for quality system improvement., • Maintain independence and oversight for clients documentation review and approval., • Reviews and approves protocols and final reports; escalate deviations from performance standards to their management., • Monitors and manages clients CAPA’s non-conformances and customer complaints., • Managed writing and review operating procedures (OP’s) to ensure compliance, efficiency and clarity., • Writing and reviewing quality system work instructions., • Responsible for conducting and/or supporting audit finding investigations including but not limited to mitigation, corrective action(s) and preventive action(s) where applicable. Collaborate with department managers to develop and implement sustainable remediation action plans., • Leads continuous improvement projects for multiple sites., • Actively participates in assigned quality facilities projects., • Implement quality compliance processes (i.e. work instructions) and other harmonization processes at multiple sites., • Act as a point of contact for customers, suppliers, and internal employees regarding all contracts and compliance requests., • Work with all necessary internal departments to ensure compliance requirements are achieved as related to industry and customer expectations based on customer driven goals., • Management of all regulatory aspects including external and internal audits, investigations, and corrective/preventive actions., • Ensure the adherence of our employees to the standard operating procedures (SOPs) established by the clients., • Manage an internal audit process to assure the adherence of the client SOPs 20. Any other duties as required by Quality and Customer Services Director to support normal client’s operations Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR 2K3ooqDVpb

Job DescriptionDescription: About the Company As a life science company and a leading supplier to global research markets, we offer a comprehensive product portfolio along with outstanding hands-on customer service to ensure every laboratory has the tools and support they need. Our markets include pharmaceutical and biotechnology businesses, research institutions, hospitals, reference labs, and more. Be part of making a difference At Genesee, we believe we can help improve our communities and transform the world through science. Our shared desire to make a difference is what drives and inspires us. We are a fast-growing, dynamic team that listens to each other and embraces collaboration. We foster an open, friendly work environment and show up for one another every day. Role: Sr. Accountant Reports to: Corporate Controller FLSA: Exempt Location: El Cajon, CA Why is this Role Important at Genesee Scientific? The Sr. Accountant will be responsible for performing a wide range of accounting and financial reporting duties, ensuring compliance with U.S. GAAP, Sarbanes-Oxley requirements, and company policies. This role will play a critical part in maintaining accurate financial records, supporting audits, and driving continuous improvement in financial processes and controls. Requirements: What will you do: • Manage and execute key month-end close activities, ensuring timely and accurate completion of assigned tasks, • Manage accounting transactions and implement system solutions to enhance the efficiency and accuracy of financial reporting, • Build cross-functional relationships across departments to support company initiatives, ensuring adherence to policies; identify and escalate key issues to senior leadership, partnering to drive problem-solving and decision-making, • Recommend and implement changes to strengthen the internal control environment, • Contribute to the preparation of budgets, forecasts, and financial analyses as needed, • Oversee the processing of accounts payable and receivable, ensuring transactions are recorded correctly and reconciled regularly What you will bring: • Bachelor’s degree in accounting or finance required, • CPA certification required, • 5+ years of experience in accounting field, 3 years in public accounting preferred, • Strong understanding of financial accounting standards and internal controls, • Proficient in Microsoft Excel; experience with ERP systems such as Sage, • Strong analytical skills with the ability to interpret financial data, • Experience in implementing and improving business processes and systems, • Excellent attention to detail and organizational skills, • Strong problem-solving abilities and a proactive approach to challenges, • Ability to work independently and as part of a team, with effective communication skills Physical Requirements: Perform the following tasks, with or without reasonable accommodation: • Primarily sedentary work performed in a climate-controlled office environment, • Regularly required to sit for extended periods, • Occasional standing and walking within the office area At Genesee Scientific, you can have a good job that can grow into a great career. We offer: • Training and professional growth initiatives, including comprehensive onboarding programs for new team members, • We provide financial well-being with competitive compensation packages and 401 (k) retirement savings plans., • Health care and well-being programs including medical, dental, vision, Life, short- and long-term disability and Employee assistance programs, • Paid time off-Vacation, Sick and 12 Holidays Candidates must be legally authorized to work in the United States without the need for current or future employer sponsorship. Employment offers are subject to successful completion of a background check and pre-employment drug test. Genesee Scientific is proud to be an Equal Employment Opportunity employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

Job Description Job Title: Director Product Quality Location: San Diego, CA (Open to RELOCATION candidates!) Type: Direct Hire Compensation: $200 - $240K + Bonus Work Model: Onsite Hours: 40.0 Overview We are seeking an experienced Director of Product Quality to lead and strengthen our Quality Engineering and Quality Control (QC) functions. This strategic leadership role is responsible for driving product quality excellence across new product development, manufacturing, supplier quality, and sustaining operations. The ideal candidate will be a hands-on quality leader with deep expertise in quality systems, root cause investigations, CAPA, validation, risk management, and statistical analysis within the IVD, Medical Device, or Pharmaceutical industries. The successful candidate will bring a strong background in Quality Engineering and Quality Control (QC). along with proven people leadership experience. NOTE: Open to RELOCATION CANDIDATES! Will compensate for relocation. Responsibilities • Lead, develop, and mentor the Product Quality organization, including Quality Engineering for new product and sustaining activities and Quality Control teams focusing on Incoming and QC Lab final Inspection, and Quality Release, • Partner closely with Manufacturing, R&D, Operations, Supply Chain, and site Quality leadership to drive quality performance and business results, • Play a critical role in strengthening root cause analysis, improving CAPA effectiveness, and building organizational capability in structured problem solving, • Build high-performing teams with clear accountability, strong technical capability, and a continuous improvement mindset, • Establish effective goals, metrics, and operating mechanisms for the Product Quality function, • Champion the use of appropriate analytical and statistical techniques across the organization to support informed decision making, root cause analysis, and proactive risk mitigation, • Lead cross functional, high impact quality initiatives, provide deep technical guidance, and ensure alignment between quality objectives and broader business goals, • Drive continuous improvement initiatives for manufacturing processes, identifying and addressing quality issues through root cause analysis, corrective and preventive actions (CAPA), and statistical process control, • Serve as the site’s subject matter expert on statistical tools and methodologies, • Oversee the application of quality engineering principles in product design and development, including design controls, risk management, and design validation activities, • Collaborate with Supply Chain and R&D to establish and maintain a robust supplier management program, including supplier selection, auditing, and performance monitoring, • Ensure departmental and site wide activities are conducted in full compliance with applicable regulatory requirements, industry standards, and internal quality systems, • Support internal and external audits, • Work with Quality Leadership to establish priorities and goals for risk management, failure analysis, process validation, process capability, trend analysis, statistical quality control and process control, • Serve as a point of contact for complex or high-risk quality issues and decisions Requirements, • Bachelor’s Degree required; Engineering degree preferred; minimum of 15 years relevant work experience including in-depth experience in Quality Engineering (QE) and Quality Control (QC), • Minimum 10 years supervisory experience, • Experience from the In Vitro Diagnostics (IVD) industry preferred, but open to Medical Device and Pharma, • Hands-on role with expert knowledge of Quality Engineering principles including risk management, root cause investigation, and descriptive and inferential statistics, • Strong hands-on validation experience (process validation, software validation, CAPA processes), • Expert knowledge of quality analysis tools such as cause-and-effect diagrams, Pareto charts, run charts, scatter diagrams, and regression analysis, • ASQ Certified Quality Engineer required, • Strong statistical tools experience, managing and personally utilizing data analysis tools, • Experience working with Cartridges & Assays is a plus, • Six Sigma Black Belt certification is a plus System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M3 Ref: #558-Scientific

Job Description Job Description: The (Sr.) Clinical Trial Manager (CTM) is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory requirements. Responsibilities: • Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives., • Proactive management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines., • Ensure the successful execution of clinical trial activities with the study team, clinical CROs and other clinical study providers (e.g., core labs, independent contractors) on time, with pre-approval inspection readiness and on budget., • Generate and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicate issues to Team Members/Vendors, with escalation as appropriate., • Maintain and report metrics for trial tracking and clinical site performance, including site activation, patient enrollment and retention., • May perform clinical data review of patient profiles, data listings and summary tables, including query generation., • Develop and/or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Study Guides/Manuals, Protocol Deviation Plan, Timelines, etc., • Develop, review and/or provide input to patient information/consent/assent, eCRF forms and completion guidelines, pharmacy manual, site instructions and study forms/site binders, etc., • Review and/or approve of IP release packages., • Review monitoring reports and other study documentation as required including tracking of such to align with visit forecasting for data centered monitoring., • Oversight of the collection, provision of documents, and management of clinical trial document filing in the Trial Master File (TMF) and QC., • Participation in team meetings and collaborate with other functional groups within the company and project team (e.g., Medical, Data Management, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals., • Follow up on assigned team action items and identification, escalation, and resolution of issues., • Collaboration with contracts specialist/Legal to review and negotiate Clinical Trial Agreements and review of site-specific study budgets., • Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP., • Oversee vendor site visits, and may conduct site visits (e.g., training visits, site initiation visits, monitoring visits), if required., • Manage investigational product accountability and reconciliation process in conjunction with CMC/RTSM., • Assist with/review of safety, interim and final clinical study reports, and resolution of data discrepancies., • Provide clinical trial support, mentoring, leadership, guidance, and direction to others assigned to the project(s)., • Serve as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies., • Review protocol deviations, risk, issues and any other data/trackers/listings., • Support safety reporting in conjunction with vendor/pharmacovigilance., • Support the management, tracking and oversight of clinical site budgets/payments in relation to conduct of a clinical trial., • Manage IRB/IEC and regulatory submissions, as needed., • Establish vendor management plans and review quality metrics., • Other duties as assigned. Qualifications: • BA/BS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent experience).., • 8+ (10+ for Sr.) years of managing Phase 1-3 clinical trials at biotech/pharmaceutical and/or CRO., • Ability to work across global time zones (including EU, APAC)., • Experience in performing clinical site monitoring visits, including remote visits, preferred., • Experience in CRO/Vendor management (domestic/international)., • Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements., • Proficiency working with Microsoft Office Suite Products, EDC, RTSM, CTMS, eTMF., • Ability to timely read, manage, respond and use of email for efficiency and communication., • Ability to travel domestically and internationally if necessary., • Understanding of project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional, and external stakeholders., • Global clinical trial experience preferred., • Small to mid-size biotech/pharmaceutical experience preferred. Required Key Attributes: • Must be able to work independently as well in cross-functional team settings with minimal supervision as needed., • Excellent written and verbal communication skills., • Strong problem-solving skills and a proactive attitude, • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Job Description About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com. Job Summary: Artiva Biotherapeutics is seeking a skilled and highly motivated Senior Scientist I/II who will be responsible for translational assay oversight and data analysis in support of ongoing clinical trials. This position will work with senior translational leadership to identify pharmacodynamic and predictive biomarkers associated with NK cell-mediated clinical response. The ideal candidate brings prior translational science experience supporting clinical trials, a strong background in immunology (B-cell immunology preferred), and hands-on expertise in flow cytometry analysis. The successful candidate will contribute to biomarker development and analysis to support ongoing clinical trials in autoimmunity. Key Responsibilities: • Perform cutting-edge translational research related to autoimmune diseases., • Develop and conduct cell-based assays such as immunophenotyping, cytotoxicity, immune cell proliferation, serum cytokine/chemokine analysis., • Perform quality control (QC) of flow cytometry data, including panel QC checks, staining and compensation controls, and ongoing monitoring of assay performance metrics., • Work within Translational team to support clinical biospecimen characterization, data analysis, and reporting of results in the form of presentation or written reports for ongoing clinical trials., • Present findings at scientific conferences and contribute to manuscript preparation for peer-reviewed publications., • Leverage prior translational science experience to support clinical trial activities end-to-end, partnering with Clinical Operations and Clinical Development on biomarker strategy, sample logistics, and interpretation of clinical trial data., • Process human clinical samples for biomarker analysis., • Ensure compliance with protocols, SOPs and work practices., • Comply with standard laboratory procedures and company policies, including notebook documentation and safety protocols. Requirements • PhD in immunology, life sciences or related discipline, with at least 5+ years of experience (6-7 years for Level II) or MS degree with 10+ years of experience within the biotechnology or pharmaceutical industry. Prior experience in translational science supporting clinical trials is preferred., • Expertise in multi-parameter flow cytometry, including panel design, sample acquisition, data processing/analysis and QC; and immune cell functional assays (e.g. proliferation, cytokine production, cytotoxicity)., • A strong background in human immunology required, with an emphasis in B-cell immunology/biology desirable. Direct experience working in autoimmunity preferred., • Prior experience in translational science with direct involvement in clinical trials (e.g., biomarker sample analysis, clinical data reporting, cross-functional collaboration with Clinical Development/Operations, and Data Management) strongly preferred., • Strong understanding of drug development., • Ability to work both independently and as part of a team, attention to detail and data quality, and excellent communication and interpersonal skills are required., • Excellent computer skills with experience using flow cytometry analysis software, including FlowJo, OMIQ, GraphPad PRISM and Microsoft Office. Competencies: • Decision Making, • Attention to Detail, • Time Management, • Strategic Thinking, • Analysis & Reporting, • Written & Verbal Communication, • Cross-Functional Leadership & Mentoring In addition to a great culture, we offer: • A beautiful facility, • An entrepreneurial, highly collaborative, and innovative environment, • Comprehensive benefits, including:, • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $149,000 - 183,000 annually. Exact compensation may vary based on level, skills and experience.

Job Description Who We Are JuneShine Brands was built by people who believe you shouldn't have to choose between living well and working hard. Our founders met through a shared love of surfing, the outdoors, and chasing experiences worth having. That spirit still runs through everything we do. We are a company with a purpose beyond profit. Every brand we build exists for a reason. We believe the next generation of consumers will choose brands that reflect their values, and we intend to build exactly those brands. We hire exceptional people and get out of their way. Flexible hours, no micromanagement, and trust as the default - we take cues from Yvon Chouinard's Let My People Go Surfing, a book we give every new hire on day one. What we ask in return is simple: own your work, deliver with excellence, and never let flexibility come at someone else's expense. We value people who are hungry and humble, who take ownership without being asked, who move fast without cutting corners, and who make everyone around them better. If that sounds like you, we'd love to meet you. What You'll Do This is the role that keeps every batch, every result, and every release held to the standard our consumers trust. As Quality Analyst, you'll report to the Director of Quality and own the hands-on lab work and quality checks across JuneShine Brands' entire portfolio - as we scale production across multiple co-manufacturing partners without cutting corners on quality. Responsibilities: • Own the review and approval of documentation required for finished goods release - Certificates of Analysis (COAs), batch records, and package records - ensuring full compliance with microbiological, organoleptic, packaging, and regulatory specifications, • Operate, calibrate, and maintain lab instrumentation (pH meters, autotitrators, NIR spectrometers, CO2/DO analyzers, flow cytometers) to ensure accurate, reliable results, • Track and trend quality data across spreadsheets and quality databases, supporting data integrity and early identification of process shifts, • Monitor for out-of-trend data and support troubleshooting of quality issues - fermentation delays, out-of-spec analytics, sensory concerns - escalating findings as needed, • Execute microbiological testing on in-process and finished materials, including media preparation, equipment sterilization, and microbial identification, • Maintain the finished product library to support internal investigations, shelf-life evaluations, and retain sample traceability, • Perform benchtop formulations to support ingredient qualifications, quality concessions, and risk assessments, providing data-driven recommendations to cross-functional partners, • Contribute to quality optimization projects and continuous improvement initiatives across the Quality Department, • Lead investigations in response to Quality Incidents, from root cause analysis through corrective action, • Adhere to all SOPs, GMPs, and safety protocols to maintain a compliant, safe work environment, • Perform other related duties, responsibilities, and special projects as assigned based on business needs and organizational prioritiesMust-Haves:, • Age 21 or older at the time of application, • College degree in Food Science, Microbiology, Chemistry, or a related field, • Minimum of 1 year of professional experience working in a laboratory environment within the Nutraceutical, Biotechnology, Pharmaceutical or Food Manufacturing industry, • Fundamental understanding of food & beverage manufacturing; including batching processes, in-process quality checks, equipment cleaning, GMPs, etc., • Familiarity with basic experimental design and execution, • Must be able to work 4-10 hour shifts (Monday-Thursday)Nice-to-Haves:, • Certifications in Food Safety, cGMP, GFSI, Quality Management, or brewing/fermentation program, • Familiarity with hemp-derived THC beverage manufacturing and complianceCompensation, Benefits + Perks: Compensation: • $30.00 - $33.00 per hour, • The final offer will be based on several factors, including experience, skills, location, and overall expertise Perks + Benefits: • Paid Time Off, • Paid sick leave in accordance with state and local laws, • Healthcare coverage: up to 90% company contribution for employees and 25% for dependents, • Voluntary vision, dental, and accidental plans, • 401(k) with up to 4% company match, free financial coaching, student loan match support, and 529 education savings accounts, • 12 weeks of paid Equal Parental Leave, $500 Baby Bonding Bucks, and a sustainable baby gift, • Dedicated parental leave support, including a personalized dashboard, full pay transparency, and a specialist to handle every logistical detail so you can focus on your family, • Product and soft goods discounts & perks, • And more!* JuneShine Brands is a purpose-driven organization composed of a diverse and dynamic group of individuals with varied backgrounds, passions, and beliefs. We are committed to fostering an inclusive environment where everyone’s unique perspectives are valued. We seek to hire self-motivated, independent thinkers, who embrace challenging the status quo. Join us at JuneShine Brands where you’re encouraged to bring your authentic self to your craft every day. As a proud equal opportunity employer, we are dedicated to ensuring fairness and equity in our hiring practices. You must reside in the United States to be considered for this position. This role supports multiple beverage brands within the JuneShine Brands portfolio, including alcohol and hemp-derived THC beverages. All Juneshine Brands products are intended for adults 21+. ©2025 Juneshine Brands| www.juneshine.com | www.drinkwillies.com | www.flyingembers.com | Please enjoy responsibly. All rights reserved. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionDescription: The Senior Associate, QC Microbiology is responsible for performing and reviewing routine environmental) and utilities monitoring of the cGMP manufacturing facilities. Conduct review of microbiological and chemical testing including endotoxin, bioburden, total organic carbon (TOC), and conductivity to support product release and facility compliance. Additional responsibilities include performing data trending, supporting method validation activities, and the drafting of protocols, reports, and SOPs related to microbiological operations. The role also involves timely and compliant reporting of test results and participation in investigations as needed. Job Responsibilities: • Perform Bioburden and endotoxin testing of in-process and products samples., • Environmental monitoring (EM) of classified cleanrooms and controlled areas., • Collect and test water samples from purified water and WFI systems., • Revise SOPs and Test Methods as required., • Review data generated in the Microbiology lab., • Execute method suitability testing, performance qualifications and various studies., • Conduct investigations of microbiological Quality Events and support CAPA implementation., • Collaborate cross-functionally with Manufacturing, QA, and Validation teams., • Author quarterly and yearly trend reports., • Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements., • Other duties as assigned.Requirements: Education and Experience • BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience., • BS with 3 years or MS degree with 0-3 years of progressively responsible experience in pharmaceutical or biologics production environments, or equivalent combination of education and experience. Knowledge, skills and abilities • Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices., • Knowledge of standard laboratory equipment., • Basic understanding of microbiological techniques, aseptic practices, and laboratory safety., • Good organizational and problem-solving skills., • Ability to follow written procedures and work in a regulated environment., • Must always adhere to good documentation practices., • Detail oriented with strong written and verbal communication skills., • Ability to work independently, within prescribed guidelines, or as a team member., • Willingness to work in cleanroom settings and handle biohazardous materials under proper PPE and gowning protocols., • Experience with Microsoft suite (e.g. PowerPoint, Word, and Excel).

Job Description The Director, Total Rewards is a strategic leader responsible for overseeing the design, administration, governance, and continuous improvement of the company's global compensation, equity, benefits, and will assist with People Business Systems programs. Reporting directly to the Chief People Officer, this role serves as a trusted advisor to executive leadership and is a key partner to Finance, Legal, and Information Technology. This Director/Senior Director will lead all aspects of the company's total rewards strategy, ensuring programs are competitive, equitable, compliant, and aligned with business objectives. This role will play a critical leadership role in Compensation Committee activities, including executive compensation, equity programs, market benchmarking, and Board-level reporting. Additionally, the position will assist with strategic oversight of People Business Systems, including Workday, ADP, and Applicant Tracking Systems, ensuring data integrity, operational efficiency, and scalable infrastructure to support organizational growth. Key Responsibilities Total Rewards Strategy • Develop and execute a comprehensive global total rewards strategy aligned with the company's business objectives and growth plans., • Design, implement, and continuously evaluate compensation, equity, and benefits programs to attract, retain, and motivate top talent., • Ensure programs are market competitive, fiscally responsible, and support a high-performance culture., • Provide strategic recommendations to executive leadership regarding compensation philosophy and total rewards investments. Compensation • Lead all global compensation programs, including base pay, incentives, recognition programs, and executive compensation., • Oversee annual compensation planning, merit increases, bonus programs, promotions, and salary structure management., • Conduct market pricing, benchmarking, and competitive analyses., • Partner with Finance to support workforce planning, labor cost forecasting, budgeting, and compensation modeling., • Develop compensation analytics and reporting to inform leadership decisions. Equity Management • Lead the administration and strategic design of the company's equity programs., • Partner with Legal and Finance to manage stock option, RSU, and other long-term incentive plans., • Ensure compliance with applicable securities regulations, tax requirements, and corporate governance standards., • Support equity planning for new hires, promotions, retention programs, and executive compensation. Benefits • Oversee the company's global benefits strategy and programs., • Evaluate and enhance health, wellness, retirement, leave, and other employee benefit offerings., • Manage vendor relationships, contract negotiations, and annual renewals., • Ensure compliance with all benefit-related regulatory requirements., • Develop communication and education strategies that improve employee understanding and utilization of benefit programs. Compensation Committee and Executive Compensation • Serve as the primary People & Performance leader supporting Compensation Committee activities., • Prepare Compensation Committee materials, analyses, presentations, and recommendations., • Partner with the Chief People Officer, CEO, Legal, and Finance leaders on executive compensation strategy., • Manage executive compensation benchmarking and governance processes., • Support Board and Compensation Committee meetings through data analysis, reporting, and strategic recommendations. People Business Systems & HR Technology • Assist with strategic oversight for People Business Systems, including ADP, Workday, Applicant Tracking Systems, and related platforms., • Partner with Information Technology to establish system governance, security, integrations, and automation initiatives., • Develop workforce analytics, dashboards, and reporting capabilities to support business decision-making. Compliance & Governance • Ensure compliance with compensation, equity, benefits, privacy, and employment-related regulations., • Partner closely with Legal on governance, executive compensation, and regulatory matters., • Establish and maintain strong internal controls, policies, and audit readiness., • Monitor legal and regulatory developments affecting total rewards programs. Leadership & Cross-Functional Partnership • Serve as a key member of the People & Performance leadership team., • Build strong partnerships with Finance, Legal, Information Technology, and executive leaders., • Lead and develop team members while fostering operational excellence and accountability., • Support strategic initiatives and organizational growth through data-driven recommendations and scalable people programs. Required Qualifications • Bachelor's degree in Human Resources, Finance, Business Administration, or related field., • 10+ years of progressive experience in compensation, benefits, executive compensation, and/or total rewards., • 5+ years of leadership experience managing Total Rewards or Compensation functions., • Deep expertise in executive compensation, compensation committee governance, equity administration, and benefits strategy., • Significant experience with HR technology platforms, including Workday, ADP, Applicant Tracking Systems, and related tools., • Strong understanding of compensation regulations, securities compliance, and benefits governance., • Experience preparing materials and analyses for Compensation Committees and Boards of Directors., • Advanced analytical, financial modeling, and business acumen capabilities., • Exceptional communication and executive presentation skills. Preferred Qualifications • Master's degree in Human Resources, Finance, Business Administration, or related field., • Certified Compensation Professional (CCP), Certified Employee Benefits Specialist (CEBS), or similar certification., • Experience within biotechnology, pharmaceutical, life sciences, or other highly regulated industries., • Experience supporting publicly traded companies or organizations preparing for IPO or significant growth events., • Strong knowledge of equity compensation platforms and executive compensation consulting practices. Core Competencies • Executive Compensation, • Compensation Committee Governance, • Total Rewards Strategy, • Global Compensation Design, • Equity Administration, • Benefits Strategy, • HR Technology Leadership, • Financial Acumen, • Data Analytics, • Executive Presence, • Compliance & Risk Management, • Cross-Functional Partnership, • Strategic Influence, • Change Leadership Compensation: • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • Paid Sick, Jury Duty, Bereavement Work Authorization: • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Disclosure Statement • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Job Description Environmental, Health & Safety (EHS) Professional Location: San Diego, California Occupational Services, Inc. (OSI) is seeking an experienced EHS Professional to join our San Diego team. This position will support clients across various industries by developing practical solutions that improve workplace safety, maintain regulatory compliance, and reduce environmental and occupational risks. Responsibilities • Develop and implement written safety programs, policies, procedures, and site-specific plans., • Review and update existing safety programs to address regulatory requirements and industry best practices., • Conduct workplace EHS inspections, audits, and risk assessments., • Evaluate compliance with Cal/OSHA, environmental, and fire code requirements., • Conduct incident investigations and recommend corrective actions., • Provide employee safety training and technical guidance., • Assist clients with hazardous materials management, emergency preparedness, and regulatory reporting., • Prepare clear, professional reports, proposals, and client communications., • Manage multiple projects while maintaining schedules, budgets, and high-quality deliverables., • Build strong professional relationships with clients and regulatory agencies. Required Qualifications • Bachelor’s degree in occupational safety, environmental health, industrial hygiene, environmental science, or a related field., • At least five years of professional EHS experience., • Demonstrated experience developing and implementing workplace safety programs., • Working knowledge of Cal/OSHA regulations., • Strong written and verbal communication skills., • Ability to work independently and manage multiple client projects., • Strong attention to detail and sound professional judgment., • Proficiency with Microsoft Office applications. Preferred Qualifications • Experience in biotechnology or pharmaceuticals., • Knowledge of hazardous materials, industrial hygiene, ergonomics, emergency response, and environmental compliance., • Professional certification or progress toward certification, such as CSP, CIH, CHMM, or ASP. OSI Benefits • Medical and dental insurance., • 401(k) retirement plan with a 6% company match., • Monthly bonus potential., • Paid vacation and company holidays., • Flexible work schedule with remote-work opportunities when project responsibilities allow., • Professional development and continuing education support., • Career-growth opportunities., • Opportunities to work with varied industries, facilities, and EHS projects., • Travel opportunities to client locations throughout California and other regions of the United States., • Collaborative and supportive team environment. Compensation: $85,000–$120,000 per year, depending on qualifications, experience, professional certifications, and relevant industry expertise. This position is also eligible for monthly bonus opportunities and OSI’s comprehensive benefits package. \nCompany Description Occupational Services, Inc. (OSI) is a nationally recognized EHS consulting firm headquartered in San Diego, California. Since 1988, we have partnered with leading biotechnology, pharmaceutical, healthcare, and manufacturing organizations to deliver high-quality industrial hygiene, occupational safety, radiation safety, and ventilation testing services throughout the United States. Occupational Services, Inc. (OSI) is a nationally recognized EHS consulting firm headquartered in San Diego, California. Since 1988, we have partnered with leading biotechnology, pharmaceutical, healthcare, and manufacturing organizations to deliver high-quality industrial hygiene, occupational safety, radiation safety, and ventilation testing services throughout the United States.

Job Description About Company: Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. About the Role: The critical role of Food Quality Assurance Auditor will perform food quality, food safety, and physical safety audits as required per the requirements of the USMC contract. This is an on-site position that will rotate among the military base dining facilities which include mess halls, kitchens, loading docks, bathroom facilities. Maintains close working relationship with the Mess Hall managers and subcontractors on all quality and safety issues. Maintains liaison with the Base Quality Assurance Evaluators (QAE) and other customer representatives on project performance and service matters. Performs several daily inspections and audits to ensure contractual and regulatory compliance. Assists the mess hall managers and subcontractors in maintaining a viable customer service program. Provides monthly in-service training to hourly employees at the base mess halls. Basic Education Qualifications: • Legal Age: 18 Years Old, • Education or Equivalent Experience: BA/BS or In Hospitality, Food Science Technology, or related field, • Supervisory/Managerial Experience: 2 years, • Certification Requirements: ServSafe certified. Primary Duties and Responsibilities: • The coordinator maintains a close working relationship with the Mess Hall managers and subcontractors on all quality and safety issues., • The coordinator will also provide mentoring/coaching/training assistance to mess hall management and employees as it relates to addressing areas of non-conformance, preparation for client and/or third-party audits, as well as meeting contractual requirements., • Maintains liaison with the Base Quality Assurance Evaluators (QAE) and other customer representatives on project performance and service matters., • Assists the mess hall managers and subcontractors in helping to drive continuous improvement in customer satisfaction and other areas as they relate to service to the client., • Attention to detail in the areas explained in the audit guidance policies as well as an understanding of areas of compliance valued by the client is a must., • The ability to discern between a food safety and/or food quality observation that affects the client and one that does not will be key to developing a good rapport/working relationship with mess hall management while ensuring contractual and regulatory requirements are being met., • An understanding of the FDA Food Code and/or the Tri Service Food Code (TSFC) is needed. Typical Knowledge & Skills: • An understanding of the FDA Food Code, • HACCP, • Safety Leadership and Investigation skills, • Customer Service skills, • Managing Multiple Priorities, • Perform Technical Tasks, • Regulatory Compliance, • Quality Control Protocol, • Auditing & Reporting Skills Basic Functional Experience: • 2 years of experience working Physical Qualifications: • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • While performing the duties of this job the employee is:, • Frequently required to climb or balance and stoop, kneel, crouch and bend., • Regularly required to stand, walk for extended periods of time, and sit; use hands to finger, handle or feel; reach with hands and arms; and talk, hear or smell and taste. The employee must occasionally lift and/or move up to 25 pounds., • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Working Environment: • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • While performing the duties of this job the employee is exposed to working in:, • Kitchen environment among industrial appliances, machines. Dish machines, ovens etc. risk of slips and falls., • Outdoor weather conditions; risk of slips and falls., • Regularly exposed to wet or hot/humid conditions [non-weather], working near moving parts., • Steps, stairs and or ladders, • High paced at times, • The noise level in the work environment is usually low to moderate conditions. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR QXRviEXS9N

Job Description Job Title: Analytical Chemist — Protein, RNA & Lipid Characterization (Ph.D.) Location: San Diego Job Type: Full-Time About Us: A new stealth-mode biotech focused on in vivo gene editing. Job Summary: We are seeking a highly skilled Analytical Scientist to join our team in a hands-on, lab-based role. The successful candidate will be responsible for developing, validating, and executing analytical methods for the characterization of proteins, RNA, and lipids central to our lipid nanoparticle (LNP) gene editing platform. This role requires deep expertise in LC/MS and complementary analytical techniques, with the ability to independently design experiments, troubleshoot complex analytical challenges, and deliver high-quality data to support research, process development, and regulatory submissions. The Analytical Scientist will serve as a subject matter expert across the organization on bioanalytical methodologies. Title and salary commensurate with experience. Key Responsibilities: • Design, develop, optimize, and validate analytical chemistry methods for the characterization of proteins (e.g., Cas9, antibody constructs), mRNA, gRNA, and lipid components using LC/MS (intact mass, peptide mapping, oligonucleotide analysis, lipidomics)., • Perform routine and non-routine hands-on analyses in the laboratory; operate, maintain, and troubleshoot LC/MS instrumentation (e.g., Q-TOF, Orbitrap, triple quadrupole) and associated sample preparation workflows., • Develop and execute orthogonal analytical chemistry methods including but not limited to HPLC/UPLC (RP, SEC, IEX, HILIC), capillary electrophoresis, UV/Vis spectrophotometry, and fluorescence-based assays., • Characterize LNP drug product attributes including lipid composition and ratios, encapsulation efficiency, RNA integrity, protein identity and purity, and post-translational or chemical modifications., • Support formulation development, process development, and stability studies by providing timely, high-quality analytical data and interpretation., • Author and review analytical methods, protocols, technical reports, and SOPs to support research activities and future regulatory filings., • Analyze and interpret complex mass spectrometry datasets; present findings to cross-functional teams and contribute to program-level decision-making., • Evaluate and implement new analytical technologies, software tools, and workflows to improve throughput, sensitivity, and data quality., • Collaborate closely with formulation scientists, biologists, process development, and CMC teams to ensure analytical needs are met across programs., • Maintain laboratory equipment, consumable inventories, and ensure compliance with safety and data integrity standards. Qualifications: • D. in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, or a related field with 5+ years of industry experience; or M.S. with 8+ years of relevant industry experience, or B.S. with 10+ years of relevant experience., • 3+ years of industry or postdoctoral experience in bioanalytical method development and characterization of biopharmaceuticals, nucleic acids, or lipid-based drug products., • Extensive hands-on experience with LC/MS platforms (Q-TOF, Orbitrap, or triple quadrupole) for protein, oligonucleotide, and/or lipid analysis., • Proficiency in chromatographic techniques (RP-HPLC, SEC, IEX, HILIC) and associated data analysis software (e.g., MassLynx, Xcalibur, Empower, BioPharma Finder, UNIFI)., • Strong understanding of protein characterization (intact mass, peptide mapping, glycosylation, disulfide mapping) and/or nucleic acid analysis (RNA integrity, modification mapping, sequence confirmation)., • Demonstrated ability to independently design experiments, interpret complex datasets, and communicate results clearly in written and oral formats., • Strong problem-solving skills and ability to manage multiple projects in a fast-paced environment. Preferred Qualifications: • Experience with lipid nanoparticle characterization and/or lipidomics by LC/MS., • Familiarity with mRNA and guide RNA analytical characterization (e.g., capillary electrophoresis, IP-RP-HPLC, LC/MS-based modification analysis)., • Experience supporting GMP or GLP analytical activities, method validation per ICH guidelines (Q2/Q14), or contributing to regulatory submissions., • Knowledge of gene therapy or gene editing product development and associated analytical expectations., • Experience with mass spectrometry-based quantitative assays (e.g., MRM/SRM for lipid or protein quantitation). Benefits: • Competitive salary, equity, and benefits package., • Opportunities for professional growth and development., • Fast-paced collaborative and innovative work environment. How to Apply: Interested candidates should submit their resume and a cover letter detailing their relevant experience. To be considered for the role, applicants must be: • Eligible to work in the United States for any employer without sponsorship., • Able to work onsite in the lab located in San Diego., • A direct candidate and not from a third party, i.e. staffing agency. Salary Range: $110,000 - $140,000

Job Description We are seeking a motivated and qualified individual to join our team as Director, Clinical Quality Assurance. This role provides strategic and operational leadership for the Clinical QA function, ensuring the highest standards of Good Clinical Practice (GCP) compliance across all clinical programs. This role is responsible for building and maintaining a robust, risk-based quality framework that supports all stages of clinical development, regulatory submissions, and sustained inspection readiness. The role will serve as a key partner across functions, driving a culture of quality, compliance, and continuous improvement. Essential Responsibilities: • Develop and execute the Clinical QA strategy aligned with organizational and development goals, • Develop, implement, maintain and continuously improve phase-appropriate, risk-based clinical. quality systems, processes, SOPs and policies to support early and late phase clinical trials and regulatory submissions., • Implement proactive, risk-based approaches to identify, assess, and mitigate quality and compliance risks., • Provide ongoing GCP quality oversight and support to ensure adherence to global GCP, quality and compliance requirements across all clinical programs., • Partner closely with Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biometrics, CMC, Clinical Supply Chain and study teams to proactively identify and mitigate compliance risks and ensure operational compliance., • Provide Clinical QA oversight for CROs, laboratories, and other clinical vendors. Ensure appropriate qualification, monitoring, and oversight are in place., • Review and contribute to key clinical and regulatory documents including INDs, protocols, IBs, NDAs, and other trial and submission-related materials, as applicable., • Lead the planning and execution of a comprehensive, risk-based GCP audit program (investigator sites, CROs, vendors, and processes)., • Oversee the management of audit findings and drive effective CAPA implementation., • Oversee and support investigations of deviations, noncompliance and quality events, ensuring thorough root cause analysis, CAPA implementation and proper documentation., • Lead organizational inspection readiness activities for late phase programs and global regulatory authority inspections (e.g., FDA, EMA)., • Ensure systems are inspection-ready and aligned with evolving regulatory expectations., • Serve as Clinical QA lead for regulatory inspections, including preparation, hosting, and post-inspection response management., • Support NDA/BLA/MAA submission activities from a quality perspective., • Influence and embed quality principles across the clinical development lifecycle., • Develop and deliver annual GCP training programs and quality-related trainings., • Communicate regulatory changes, best practices and compliance expectations to internal stakeholders., • Collaborate closely with the broader Quality team to execute Quality objectives and ensure alignment across GxP areas., • Foster a culture of inspection readiness and continuous improvement across the organization Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. Travel Requirements Approximately 10-20% travel may be required. Qualifications: • Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred, • 12+ years of progressive GCP Quality Assurance experience in the biotechnology or pharmaceutical industry, • Direct experience supporting late-stage clinical trials (Phase 2/3) and NDA/MAA submission preparation, with proven inspection readiness experience, • Expert knowledge of global GCP regulations and guidance, including but not limited to:, • 21 CFR Parts 11, 50, 54, 56, 312, • EU Clinical Trial Regulation (EU-CTR), • ICH E6(R2/R3), ICH E8, • General Data Protection Regulation (GDPR), • Good Clinical Laboratory Practice (GCLP), • Extensive experience leading GCP audits (internal, investigator sites, CROs, and vendors) and managing regulatory inspections, • Demonstrated ability to operate both strategically and hands-on in a small, fast-paced biotech environment, • Excellent communication, collaboration, and influencing skills across cross-functional teams Required Key Attributes: • Strategic mindset with strong execution capability, • Deep expertise in GCP and clinical development processes, • High integrity and commitment to quality and compliance, • Strong leadership and stakeholder influence, • Solutions-oriented with a proactive, risk-based approach, • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. Compensation: • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • Paid Sick, Jury Duty, Bereavement Work Authorization: • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. Disclosure Statement • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Are you looking for an opportunity to make a difference? At Mesa Labs we’re passionate about protecting the vulnerable by enabling scientific breakthroughs, ensuring product integrity, increasing patient and worker safety, and improving quality of life around the world. At Mesa Labs we offer competitive wages, including potential bonus opportunities, equity awards, commission, and a comprehensive benefits package based on the position. Base Compensation Range: $154,500.00 to $193,250.00 USD *In addition, you qualify for: • Annual bonus opportunity of 22% based on company performance., • Annual equity award of $30K. Outstanding Benefits and Perks: We are proud to offer a variety of benefits that meet the diverse needs of our employees: • Eligible for benefits the first day of the month after you start, • Tiered Medical, Dental and Vision Insurance options, Health savings (HSA), healthcare & dependent care flexible spending (FSA) accounts, • Company paid short term and long-term disability (unless covered by a state disability plan), • Company paid life insurance and AD&D, • Flexible Time Off Policy, • Paid sick leave of 48 hours per calendar year, • Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws, • 401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1, • Employee Wellness and Financial Assistance Resources through Cigna and NY Life, • Nine (9) paid company holidays per year Agena: Agena Bioscience® empowers research laboratories worldwide to deliver scalable targeted genomic data. Our open, advanced platform, the Mass ARRAY® System, provides researchers with insights through a highly multiplexed solution in the areas of mutation profiling, liquid biopsy, pharmacogenetics, and more. Job Summary: The Director of Operations serves as the senior operational leader for the site, responsible for Manufacturing, Supply Chain, Production Planning, Warehouse, Facilities, Operational Excellence, and the Quality and Regulatory organization. Reporting directly to the VP/General Manager of the business, this role is accountable for building a high-performing operation that delivers safe, compliant, efficient, and scalable manufacturing while supporting the company's strategic growth objectives. This leader serves as a key member of the site leadership team, partnering closely with Engineering, Product Development, Product Management, Commercial, Finance, Regulatory Affairs, and Customer Support to translate business strategy into operational execution. The Director is responsible for balancing customer commitments, operational performance, financial objectives, and regulatory compliance while developing future leaders and fostering a culture of accountability and continuous improvement. What You'll Own • Provide strategic and day-to-day leadership for Manufacturing, Supply Chain, Production Planning, Warehouse, Facilities, Operational Excellence, and the Quality organization., • Lead and develop the Quality Manager, Manufacturing Manager, Warehouse Manager, Supply Chain Team, and future operational leaders while building organizational capability and succession plans., • Own operational performance across safety, quality, delivery, inventory, productivity, cost, and customer satisfaction., • Develop and execute annual operating plans, workforce strategies, and operational roadmaps aligned with business objectives., • Lead Sales & Operations Planning (S&OP), capacity planning, inventory strategy, and resource planning to support revenue commitments and business growth., • Drive manufacturing readiness for new product introductions, engineering changes, manufacturing transfers, and product lifecycle management., • Partner with Engineering, R&D, Product Management, Commercial, Regulatory Affairs, and Finance to remove operational constraints, improve product manufacturability, and support commercialization efforts., • Build strong partnerships across functions to resolve complex operational challenges while balancing customer needs, business priorities, and regulatory requirements., • Lead capital planning and operational investment decisions that improve quality, capacity, efficiency, automation, and long-term scalability., • Champion Lean Manufacturing, Daily Management, problem-solving disciplines, and continuous improvement initiatives throughout the organization., • Utilize and own operational metrics and business analytics to identify trends, prioritize improvement opportunities, and drive fact-based decision making., • Ensure compliance with applicable regulatory requirements, quality systems, safety standards, and internal policies., • Serve as the operational escalation point for significant customer, quality, supply chain, and manufacturing issues., • Build an engaged, accountable culture that emphasizes leadership development, collaboration, ownership, and operational excellence. What Success Looks Like • Consistently delivers safety, quality, delivery, inventory, productivity, and financial objectives., • Develops an integrated Operations and Quality organization that operates as one team with shared accountability., • Creates scalable manufacturing systems capable of supporting business growth and future product expansion., • Successfully supports new product introductions and manufacturing transfers with minimal disruption to customers., • Builds strong cross-functional partnerships that improve execution across Engineering, Commercial, Product Management, Quality, Regulatory, and Finance., • Develops future leaders through coaching, succession planning, and talent development., • Drives a culture where continuous improvement, accountability, and data-driven decision making become standard operating practice., • Identifies and mitigates operational risks after they impact customers or business performance. Minimum Qualifications • Bachelor's degree in Engineering, Operations, Supply Chain, Business, or a related technical discipline required. Master's degree preferred., • 10+ years of progressive manufacturing or operations leadership experience, including responsibility for multiple operational functions., • Demonstrated success leading Operations and Quality organizations within a regulated manufacturing environment., • Experience supporting product commercialization, new product introduction, manufacturing transfers, and production scaling., • Strong understanding of Lean Manufacturing, Operational Excellence, capacity planning, inventory management, and production systems., • Proven ability to build high-performing teams, coach leaders, and drive organizational change., • Strong financial acumen with experience managing operating budgets, capital investments, and productivity initiatives., • Excellent executive communication and cross-functional leadership skills with the ability to influence across all levels of the organization., • Lean Manufacturing experience required; Six Sigma certification preferred., • Medical device, diagnostics, biotechnology, pharmaceutical, or life sciences manufacturing experience strongly preferred. Leadership Competencies • Strategic thinker capable of connecting operational execution to business objectives., • Builds trust and influence across cross-functional teams., • Makes timely, data-driven decisions in complex environments., • Develops people and creates strong succession pipelines., • Leads through change with resilience and accountability., • Creates clarity, alignment, and execution across multiple priorities., • Maintains a customer-first mindset while balancing quality, cost, delivery, and compliance. Work Environment Primarily onsite within a regulated manufacturing and laboratory environment with occasional domestic travel. Mesa Labs is an Equal Employment Opportunity Employer. Mesa Labs prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law. Please note that Mesa Labs conducts criminal background checks upon offer acceptance.

Job DescriptionDescription: Under supervision, the Manufacturing Technician, Production Support, will perform routine manufacturing activities in GMP manufacturing areas, solution preparation, dispensing raw material, bioprocessing support and autoclave operation. Operations will be performed according to Standard Operating Procedures (SOP), Work Instructions (WI) and Master Batch Records (MBR). Perform manufacturing steps, execute routine MBRs, and revise documents such as MBRs and SOPs as needed. Flexible shift schedules and overtime may be required. Job Responsibilities: • Perform GMP manufacturing activities in assigned areas., • Perform routine cleaning activities in GMP manufacturing areas, • Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products., • Set-up, operate, maintain and clean bioprocessing equipment., • Demonstrate good aseptic technique., • Perform dispensing raw material., • Basic troubleshooting of bioprocess equipment., • Perform manual cleaning and sterilization of parts and components., • Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices., • Draft and revise SOPs and batch records., • Address production issues and report any compliance related concerns to the supervisor.Requirements: Education and Experience: • High School Diploma, Bachelor's or advanced degree in life sciences or related discipline, or equivalent education and experience., • High school diploma with 3 or more years of experience in the pharmaceutical or biotech industry, • Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. Knowledge, Skills and Abilities: • cGMP manufacturing for biological products is preferred., • Fundamental knowledge of current biologics regulations and cGMP for drug substance operation., • Proficient with Microsoft Word and Excel., • Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions., • Demonstrated ability to follow and document activities in written procedures and/or logbooks., • Detail oriented, strong team player., • Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders., • Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.

Job Description The Executive Director of Clinical Operations will provide global operational leadership overseeing complex clinical programs focusing on innovative T-cell engager therapies for immunology and oncology indications. This role is responsible for efficient planning, resourcing and execution of portfolio level programs in adherence to ICH-GCP, FDA regulations, and company SOPs. The Executive Director will report into the Head of Project Team Leads and will ensure strategic alignment of programs and key stakeholder management in a fast-paced environment, while mentoring and growing a Clinical Operations team and culture to ensure successful program delivery. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Drive global clinical operations strategy and execution for programs ensuring all clinical activities support IND-enabling through Phase 3 objectives, as well as future clinical development plans., • Collaborate effectively cross-functionally with senior leadership to ensure operational initiatives support strategic company goals., • Establish and refine scalable best practices to drive efficiency while preparing for future departmental growth., • Oversee the development, review, and operational implementation of study documents, including protocols, informed consent forms, CRFs, monitoring plans, and pharmacy manuals ensuring consistency among programs., • Partner closely with executive leadership to shape clinical development strategy, operational plans, budget forecasts, and long-range portfolio planning across multiple programs., • Lead executive-level discussions regarding program risks, mitigation strategies, timelines, and resource allocation, ensuring alignment with corporate objectives and investor-facing milestones., • Serve as the Clinical Operations representative to Executive Leadership and governance committees, providing strategic recommendations, portfolio risk assessments, resource forecasts, and operational updates to support key business decisions., • Influence organizational strategy through the development of clinical operations capabilities, infrastructure, processes, and talent necessary to support portfolio growth., • Mentor and support direct reports, fostering professional development, team performance and a strong culture., • Oversee site strategy and establish Clinical Operations team relationships with investigators and key opinion leaders., • Ensure successful external partner relationships with CROs, central labs, patient advocacy groups and others. Ensure deliverables are met on time, within budget, and to quality standards., • Contribute to the development and implementation of SOPs, work instructions, and operational plans to enhance team efficiency and compliance., • Develop and implement operational plans, timelines, and budgets for clinical programs., • Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor’s degree in life sciences or related discipline with 15+ years of progressive clinical development and operations experience, including significant leadership responsibility within biotechnology or pharmaceutical organizations; advanced degree preferred., • Strong experience in complex autoimmune indications, early phase experience strongly preferred., • Ability to define strategy and ensure organizational goals are executed in global clinical operations plans., • Exceptional executive presence and communication skills with demonstrated success presenting complex clinical, operational, and business information to Executive Leadership Teams, governance committees, and external stakeholders., • Experience leading cross-functional teams in a matrix environment and driving alignment across Clinical Development, Medical, Regulatory, Biometrics, Translational Sciences, Safety, and Program Management., • Proven track record of leading complex clinical programs from start to completion., • Strong knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines., • Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC)., • Expertise in clinical budgeting and efficient allocation of resources, • Demonstrated success in leading, mentoring, developing diverse clinical teams and providing oversight to CROs., • Exceptional executive presence and communication skills with demonstrated success presenting complex clinical, operational, and business information to Executive Leadership Teams, governance committees, and external stakeholders., • Strong organizational and time management abilities., • High level of accountability, adaptability, and attention to detail with an ability to set priorities and handle multiple tasks simultaneously in a changing environment., • Ability to work independently and collaboratively in a fast-paced, matrixed environment. In addition to a competitive base salary ranging from $290,000 to $308,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the salary is a guideline and the individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity. Job Type: Full-time Benefits: · Annual bonus program · Incentive stock option plan · 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance · HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule: · Monday to Friday Work authorization: · United States (Required) Additional Compensation: · Annual targeted bonus % Work Location: · Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required. EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Senior Medical Scientist, Drug Safety will provide operational and scientific support in managing the development, implementation and oversight of Arrowhead investigational products with engaging in, but not limited to: support safety governance and surveillance procedures including safety reporting processes, advanced safety analytics, expedited and periodic aggregate reports ensuring compliance with internal standard operating procedures, FDA and global safety reporting requirements. They will conduct trend recognition, signal detection, and assist in overseeing relationships with vendors and business partners to ensure the highest quality of safety data is collected, reviewed and analyzed which fulfill all safety reporting requirements are met in the required timelines. This role will collaborate with Drug Safety Operations, Safety Scientists, medical monitors, clinical operations, QA, Data Management and regulatory colleagues in the set-up of and support of clinical development programs and/or post-marketed products to ensure safety oversight. This role is base onsite 5x a week at Arrowhead's Research & Development site in San Diego, CA. Responsibilities • Review potential safety observations, safety signals and contribute to the Safety Review Committee and Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic, aggregate safety data reviews, and provide recommendations for review and approval by the Executive Safety Committee, • Prepare periodic aggregate safety reports including PSUR, DSUR, FDA IND Annual Report etc., • Performs routine signal detection, identifies and evaluate safety signals, • Continually stay up to date on relevant regulations associated with the above activities, • Develop and update of Safety Surveillance Plans for assigned products, • Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports, Company Core Data Sheet, Investigators Brochure and Risk Management Plan, • Assist in quality assurance activities, including deviation reports, • Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure effective reconciliation process, • Assist with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities, • Support activities associated with launching a filing for the BLA/NDA or global marketing, • Medical Review Responsibilities, • Perform Medical Review on SAE/SUSAR if applicable, • Conduct active case follow-up, including written and verbal follow-up with clinical operations, clinical investigators and sites if applicable Requirements • MD or DO Degree, • 8 years in the pharmaceutical industry or CRO, • 5 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience, • Experience in Signal Detection and Safety Data Analytics, • Strong safety science experience to utilize data analysis and visualization platforms and tools by applying advanced scientific algorithms and methods and translating the strategic vision of safety science into risk mitigation strategies and data visualization insights, • Strong working knowledge of FDA and international adverse event reporting regulations {ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulations, • Strong working knowledge of ARGUS case management and medical review processing; experience in using ARGUS or other safety databases; experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications, post marketed and premarketed products, • Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs), • Strong interpersonal skills with the ability to professionally interact with cross functional team members Preferred • Experience in the cardiometabolic and/or rare disease space. This position may be hired at a lower level depending on the candidate's qualifications, experience, and overall alignment with the needs of the role. California pay range $185,000—$210,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job Description ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®, the first and only FDA-approved needle-free epinephrine product. If you're motivated to make a meaningful impact, this is your opportunity to join a collaborative, entrepreneurial, and inclusive culture. JOB SUMMARY The Vice President, Head of Clinical Development – Allergy & Urticaria is responsible for clinical strategy and execution across ARS Pharma's allergy and urticaria portfolio, including chronic spontaneous urticaria (CSU) and related immunology-mediated conditions. This role owns clinical trial design and program execution from early-phase proof-of-concept through global registration and serves as the organization's senior authority on the allergy/urticaria therapeutic area and its evolving regulatory landscape. The VP translates enterprise medical and evidence strategy into actionable, scientifically rigorous clinical development plans. The VP partners closely with Medical Affairs, Regulatory Affairs, Development, Technical Operations, Biometrics & Data Management, Clinical Operations, Pharmacovigilance/Safety, and Commercial/Market Access to build integrated development plans that support successful global registration and market adoption. The VP will play a critical role in building out ARS Pharma's clinical development function and team as the allergy and urticaria portfolio scales. ESSENTIAL JOB DUTIES & RESPONSIBILITIES • Own clinical strategy and execution for the allergy and urticaria portfolio, ensuring development plans reflect the latest science, competitive landscape, and unmet patient needs., • Lead the design, execution, and oversight of clinical development programs for allergy and urticaria assets, from IND-enabling studies through Phase 3 registration trials., • Lead trial design across the portfolio, including study population, endpoints, comparators, and statistical approach, in partnership with Biometrics and the C-Suite, • Translate enterprise medical and evidence strategy into detailed clinical development plans, study designs, timelines, and risk/benefit tradeoffs., • Author and oversee clinical protocols, investigator brochures, statistical analysis plans, clinical study reports, and other core clinical documents in partnership with Biometrics and Medical Writing., • Serve as the senior clinical development representative in interactions with FDA, EMA, and other health authorities, including IND/CTA submissions, End-of-Phase meetings, and Type B/C meetings., • Provide medical monitoring oversight and clinical data interpretation across ongoing studies, ensuring subject safety and data integrity., • Partner with Clinical Operations and CRO partners to ensure trials are executed on time, on budget, and to GCP/ICH standards; oversee site selection, enrollment strategy, and vendor management., • Chair or co-chair internal safety review committees and support benefit-risk decisions and post-market clinical surveillance in partnership with Pharmacovigilance, Regulatory, and Quality., • Contribute clinical development expertise to early- and mid-stage protocol design for pipeline expansion and business development opportunities in allergy, urticaria, and related immunology-mediated conditions., • Partner with Medical Affairs and HEOR/RWE colleagues to ensure clinical development plans generate evidence that supports adoption, guideline inclusion, and payer/reimbursement narratives., • Engage key opinion leaders (KOLs), investigators, and scientific advisory boards to inform trial design and endpoint selection (e.g., UAS7, CU-Q2oL, itch/hive severity scores)., • Represent clinical development in board meetings, investor updates, and partner/licensing discussions as needed., • Build, lead, and mentor a growing clinical development team (medical directors, clinical scientists, medical monitors), fostering a culture of scientific rigor, compliance, and collaboration. KNOWLEDGE, SKILLS, & ABILITIES: • Experience presenting clinical data and development strategy to regulatory agencies, scientific advisory boards, and investigator/KOL audiences., • Experience advising the executive leadership team on clinical development strategy, trial design, and risk/benefit tradeoffs., • In-depth knowledge of the allergy and urticaria therapeutic area — disease biology, standard of care, competitive pipeline, endpoints, biomarkers, and patient-reported outcome measures., • Current knowledge of the FDA, EMA, and global regulatory landscape for allergy and urticaria (and biologics/immunology programs generally), including relevant guidance documents and precedent approvals., • Demonstrated expertise in clinical trial design, including study population, endpoint selection, comparator strategy, and adaptive/innovative trial methodologies., • Experience managing global, multi-site clinical trials, including work with CROs and central labs., • Demonstrated ability to operate effectively in a hands-on, fast-paced environment with limited infrastructure and evolving organizational needs. EDUCATION AND EXPERIENCE • MD, MD/PhD, or PharmD required (MD preferred); Board Certification in Allergy/Immunology, Dermatology, or a related specialty a plus, with 12+ years of progressive clinical development leadership in the biotechnology or pharmaceutical industry., • Significant hands-on clinical development experience in allergy, urticaria (including chronic spontaneous urticaria), or related immunology-mediated therapeutic areas., • Demonstrated success leading clinical programs from IND through registration (BLA/NDA), including direct authorship of protocols and regulatory submissions., • Executive presence and ability to partner effectively with the C-Suite, and cross-functional leaders across Regulatory, Biometrics, Clinical Operations, Pharmacovigilance, and Commercial in a publicly traded environment., • U.S.-based; ability to travel domestically and internationally for key internal and partner meetings (up to 20–30%). At ARS, we are proud to offer a highly competitive compensation & benefits package. The base salary range for this position is $325,000 to $400,000 and may be eligible for performance-based incentive compensation. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law. This position is also eligible for Equity, 401k matching, and our excellent benefits package including 100% employer paid Medical, Dental & Vision for employees. View the full package here: ARS Careers Page ARS Pharmaceuticals believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. ARS Pharmaceuticals is also committed to providing reasonable accommodation to qualified individuals so that an individual can perform their job-related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at careers@ars-pharma.com The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Job DescriptionDescription: Company Overview: Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space. We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression. Vividion has been recognized as a Top Workplace by The San Diego Union-Tribune from 2022 to 2025. Job Summary: The VP, Product Team Leader (PTL) serves as the single point of accountability for the integrated strategy, decision process, and execution of assigned pipeline assets. Chairing the Product Team, this leader guides programs from development candidate and IND-enabling activities through clinical proof of concept. The PTL translates scientific, clinical, and commercial opportunities into a differentiated global product strategy and an execution-ready Integrated Development Plan. Working through empowered functional leaders, the PTL aligns scope, timelines, investment, evidence generation, and key inflection points with corporate and portfolio priorities. The role owns the integrated decision process while respecting the decision authority and technical accountability of Clinical Development, Medical, Regulatory, CMC, Safety, Clinical Operations, Biometrics, Translational Science, Commercial, and other functions. Requirements: Key Responsibilities: Strategy and Value Creation • Define the asset vision, target product profile, and value proposition by integrating patient need, scientific rationale, competitive landscape, regulatory opportunity, access, and commercial potential., • Lead indication prioritization, development scenarios, and investment choices, and establish a clear path to proof of concept with an initial view toward registration, commercialization, and lifecycle management., • Adapt strategy as the scientific, clinical, regulatory, and market landscape evolves while preserving optionality and asset value. Product Team and Decision Leadership • Chair a Product Team of empowered leaders across relevant research, development, medical, operational, commercial, legal, and finance functions., • Build an inclusive, high-accountability team culture that supports rigorous debate, transparent communication, timely execution, and collective ownership of program outcomes., • Clarify decision rights and escalation pathways, and lead integrated decisions with clear owners, criteria, options, tradeoffs, timing, and execution plans., • Lead program risk management, scenario planning, contingencies, and escalation of material changes to the appropriate governance forum. Clinical Development and Evidence Generation • Partner with the Chief Medical Officer, Clinical Development leadership, and the Clinical Development Lead to ensure clinical plans are scientifically rigorous, medically appropriate, feasible, and differentiated., • Guide protocol strategy, cohort and indication sequencing, proof-of-concept criteria, dose and regimen decisions, biomarker strategy, data-readout planning, and interpretation of emerging evidence., • Ensure cross-functional readiness for key milestones, including IND/CTA, first patient dosed, cohort expansion, recommended Phase 2 dose, proof of concept, later-stage development, filing, and launch, as applicable., • Participate in key health authority interactions and maintain alignment among regulatory strategy, clinical evidence, CMC readiness, and commercial objectives. Execution and Resource Stewardship • Partner with Program Management to maintain the integrated plan, critical path, decision calendar, risk register, governance cadence, and readiness packages., • Develop and defend program budgets and resource requirements, evaluate time-cost-risk tradeoffs, and ensure execution within approved scope and investment., • Identify cross-program dependencies and constraints, resolve conflicts with functional and portfolio leaders, and recommend enterprise-level tradeoffs., • Drive operational excellence, quality, inspection readiness, and compliance with applicable global requirements. Education and Experience: • Advanced degree (Ph.D., M.D., Pharm.D., or equivalent) required., • 15+ years of progressive pharmaceutical or biotechnology experience, with substantial leadership of complex development programs., • Demonstrated drug-development leadership, including expertise in tumor biology, translational strategy, and the competitive landscape., • Proven success executing global development strategies from early development through proof of concept and participating in major health authority interactions., • Exceptional executive communication and business acumen, with the ability to navigate ambiguity and present clear recommendations to senior leadership. Pay & Benefits: The anticipated base salary for this position ranges from $275,000 to $320,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance. EEO & Employment Eligibility: Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by applicable federal, state, or local laws. Privacy Policy: The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit https://vividion.com/privacy-notice/.

Job DescriptionPharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. By targeting this clinically proven therapeutic target with novel, oral small molecules, the Pharvaris team is advancing new alternatives to injected therapies for the prevention and treatment of hereditary angioedema (HAE) attacks, and other bradykinin B2-receptor-mediated indications. HAE is a rare and potentially life-threatening genetic disease and people living with HAE can suffer sudden and prolonged attacks of swelling in multiple areas of the body, including the airway, which can be life-threatening. We are expanding our U.S. Commercial team and are looking for an Area Business Manager – San Diego, to join our team and report to our West Zone Director. We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely. Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning, and you can make a difference – Pharvaris is the place for you! Location Field based About the Role The Area Business Manager will play a key role in driving continued growth and market expansion for an innovative oral therapy within hereditary angioedema (HAE). This individual will be responsible for developing territory strategy, building meaningful relationships with HCPs and key stakeholders, and advancing disease and brand awareness across the region. This is a highly visible field-based role requiring strong clinical selling capability, strategic thinking, cross-functional collaboration, and a passion for improving outcomes for patients living with rare disease. The ideal candidate thrives in a fast-moving, entrepreneurial environment and brings both launch experience and a strong ownership mindset. Responsibilities • Develop and execute a territory business plan focused on physician engagement, market development, and account growth, • Drive demand through clinical selling, customer education, and strategic engagement with HAE healthcare providers, • Build and maintain trusted relationships with key customers, thought leaders, and internal business partners, • Identify opportunities within the territory and adapt strategy based on market dynamics and customer insights, • Lead impactful field activities including speaker programs, educational initiatives, conference support, peer-to-peer engagement, and customer in-services, • Partner cross-functionally with Medical, Market Access, Marketing, Patient Services, and Commercial leadership to support patient access and continuity of care, • Utilize strong pre-call planning, territory analytics, and post-call assessment to continuously improve execution, • Consistently deliver against performance objectives while maintaining the highest standards of compliance and professionalism, • Contribute to a collaborative, solutions-oriented team culture with a strong focus on execution and accountabilityRequirements, • Minimum of 5+ years of biotechnology or pharmaceutical sales experience, preferably within rare disease, specialty, immunology, or allergy markets, • Product launch experience strongly preferred, • Demonstrated success managing complex territories and driving sustained business growth, • Experience engaging specialty healthcare providers and navigating complex patient access environments, • Strong understanding of compliant pharmaceutical selling practices and industry regulations, • Proven ability to work effectively across cross-functional teams in a dynamic commercial environment, • Excellent communication, organizational, and territory management skills, • Ability to travel regularly throughout the assigned geography, including occasional overnight and weekend travel, • Bachelor’s degree required; life sciences or business-related focus preferredWe Are Looking for Someone That Has:, • A strategic and proactive approach to territory ownership and business planning, • Strong clinical and consultative selling capability, • High accountability with a bias toward action and results, • The ability to influence and build credibility with both internal and external stakeholders, • Experience operating effectively in a fast-paced, evolving commercial organization, • Strong analytical thinking and the ability to translate insights into action, • A collaborative mindset paired with competitive drive and executional intensity, • Emotional intelligence, professionalism, and strong interpersonal presence, • A patient-focused mentality with a passion for rare disease and improving patient outcomes, • The confidence to operate independently while remaining highly connected to the broader team and organizational priorities Pharvaris is committed to fair and equitable compensation practices. The base salary range for this role is $160,000-$185,000 per year. Actual compensation will depend on various factors, including but not limited to relevant sales experience, demonstrated performance, skills, geographic market, and internal equity. Exceptional candidates may be considered outside of the intended hiring range. We view compensation holistically. In addition to a competitive base salary, employees are eligible for incentive compensation and equity participation, reinforcing our ownership mindset and aligning individual contributions with company success. We also provide a competitive benefits package, including medical, dental, vision, life and disability insurance, retirement savings plans with company matching, flexible paid time off, employee assistance programs, and a variety of voluntary benefits. We encourage candidates who are motivated by the full opportunity and alignment with our mission to apply, even if their current compensation falls outside the stated range. Powered by JazzHR uatKDBO43U

Job Description Apply now: Analyst II (Post-Market Complaints), location is Hybrid (San Diego, CA). The start date is ASAP for this 6-month contract-to-hire position. Job Title: Analyst II (Post-Market Complaints)Location-Type: Hybrid – San Diego, CA (3 days onsite/week minimum)Start Date Is: ASAPDuration: 6-month Contract-to-HireCompensation Range: $45-$55/hour W2Benefits: Eligible for Health, Dental, Vision, 401KMust be authorized to work in the U.S. This position is not eligible for sponsorship. Job Description The Analyst II is responsible for investigating product complaints, analyzing product data, performing risk assessments, determining root causes, and documenting findings to support product quality and continuous process improvement within a regulated medical device environment. Day-to-Day Responsibilities • Investigate customer product complaints using available product data., • Review and analyze complaint information to confirm or deny reported issues., • Perform risk assessments and determine potential root causes., • Document investigation findings and prepare clear written conclusions., • Manage a high volume of complaint investigations while meeting quality and turnaround metrics., • Identify opportunities for process improvements and workflow optimization., • Collaborate with cross-functional teams to improve complaint handling processes., • Utilize automated tools and standardized procedures to increase investigation efficiency., • Ensure compliance with quality system and regulatory requirements. Minimum Requirements • Bachelor's degree in Biomedical Engineering or a related life sciences/engineering field., • 3–5 years of experience in complaint handling within medical devices, IVD, MDR, or pharmaceutical manufacturing., • Understanding of Quality Systems, Good Manufacturing Practices (GMP), and regulated environments., • Strong analytical and critical thinking skills., • Excellent written communication skills with the ability to produce detailed investigation reports., • Strong verbal communication and interpersonal skills., • Excellent organizational and time management abilities., • Comfortable performing high-volume, detail-oriented investigative work., • Demonstrated drive, accountability, and ownership., • Interest in building a career in Quality rather than Research & Development. Preferred Qualifications • Experience supporting complaint investigations for diagnostic or laboratory instruments., • Experience with risk assessments and root cause analysis., • Knowledge of blood gas analyzers, in vitro diagnostics (IVD), or related medical technologies., • Experience identifying process improvement opportunities., • Ability to mentor or train peers on quality processes.

Job DescriptionJob Title: Calibration Technician 3Job Description The Calibration Technician 3 supports the calibration, adjustment, verification, documentation, and ongoing reliability of critical inspection, measurement, and test equipment in a highly regulated medical device manufacturing environment. This role performs hands-on calibration activities across a broad range of measurement technologies and ensures that internal procedures, required specifications, and applicable quality requirements are consistently met by both internal and external calibration services. Responsibilities • Perform precision calibration, adjustment, and verification of electronic, mechanical, dimensional, pressure, temperature, humidity, and thermal measurement equipment., • Conduct calibration and preventative maintenance activities that support equipment accuracy, reliability, and operational readiness., • Review internal and external calibration certificates, service reports, and supporting documentation for accuracy, completeness, and compliance with required specifications., • Maintain accurate calibration records, equipment history files, and associated quality documentation in accordance with cGMP and 21 CFR Part 820 requirements., • Troubleshoot calibration-related discrepancies and equipment performance issues, identifying root causes and supporting corrective actions that improve measurement accuracy and equipment reliability., • Support root cause analysis and corrective action activities related to calibration or measurement accuracy, collaborating with cross-functional teams as needed., • Coordinate equipment servicing and calibration activities with internal teams and external service providers to ensure timely completion and minimal disruption to operations., • Collaborate closely with Manufacturing, Quality Assurance, Engineering, Maintenance, Facilities, and Research and Development to support equipment readiness and quality system requirements., • Participate in meetings related to calibration processes and process improvements, contributing insights and recommendations based on experience., • Support proprietary calibration processes developed specifically for specialized equipment and products used within the organization., • Use IBM Maximo or similar systems, when applicable, to manage equipment records, calibration schedules, and maintenance activities., • Document test results clearly and accurately, and communicate findings to Quality, Engineering, Manufacturing, and other technical functions., • Contribute to continuous improvement initiatives focused on calibration processes, documentation practices, and equipment reliability.Essential Skills, • High school diploma with 2 to 4 years of related experience required., • 5 to 7 years of calibration experience in a GxP/GMP-regulated or medical device manufacturing environment strongly preferred., • Advanced understanding of calibration practices, procedures, equipment adjustment, and troubleshooting., • Advanced experience performing precision calibration, adjustment, and verification of electronic, mechanical, dimensional, pressure, temperature, humidity, and thermal measurement equipment., • Working knowledge of cGMP requirements and experience performing calibration work in a GxP, GMP, pharmaceutical, medical device, or similarly regulated environment., • Familiarity with equipment control, documentation, and quality system requirements associated with 21 CFR Part 820., • Experience reviewing calibration certificates and service reports, confirming specifications have been met, and maintaining accurate equipment histories and calibration records., • Demonstrated ability to investigate calibration discrepancies, diagnose equipment issues, support root cause analysis, and implement corrective actions., • Experience calibrating temperature, humidity, pressure, dimensional, thermal, electronic, and mechanical equipment., • Clear verbal communication skills and strong technical writing abilities for documenting test results and calibration activities., • Ability to collaborate effectively with Quality Assurance, Engineering, Manufacturing, Maintenance, Facilities, and Research and Development teams., • Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Windows-based systems., • Ability to stand for extended periods, walk between facilities, and independently lift equipment weighing up to 20 pounds.Additional Skills & Qualifications, • Pharmaceutical industry experience is highly preferred., • Experience in a medical device or similarly regulated manufacturing environment is strongly preferred., • Familiarity with IBM Maximo or similar asset management systems is preferred., • ASQ Certified Calibration Technician certification is a plus, but not required., • Experience supporting proprietary calibration processes developed for specialized products and equipment., • Background in certificate review, preventative maintenance, root cause analysis, and corrective action within a regulated environment., • Resume that demonstrates calibration accomplishments, increasing responsibility, and clear career progression rather than listing only generic duties.Work Environment This position is based onsite in a medical device and regulated manufacturing environment in San Diego, CA, working within a small calibration and quality support team. The standard schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., for a 40-hour workweek, with occasional overtime that may be available or required. The role involves hands-on work with inspection, measurement, calibration, and test equipment, including temperature, humidity, pressure, dimensional, thermal, mechanical, and electronic systems. Work may require standing for extended periods, walking between facilities, and lifting equipment weighing up to 20 pounds. The environment is highly regulated and governed by internal quality procedures, cGMP guidelines, and 21 CFR Part 820 requirements. Team members regularly collaborate with Engineering, Maintenance, Facilities, Quality Assurance, Manufacturing, and Research and Development, and the work includes a mix of equipment calibration, certificate review, documentation, troubleshooting, maintenance support, and participation in process improvement initiatives. The assignment is initially planned for 12 months with an established onsite team, with potential for extension and conversion to a full-time role, offering exposure to both standard and proprietary calibration disciplines and direct interaction across multiple business units. Job Type & Location This is a Contract position based out of San Diego, CA. Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in San Diego,CA. Application Deadline This position is anticipated to close on Oct 5, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

Job Description Beloteca, Inc. is a generic pharmaceutical development company specializing in the development of injectable products. It is desirable that the candidate have past practical experience and education in handling chemicals, operating laboratory equipment, generating and manipulating data, as well as computer database and word-processing skills. Job Description: • Independent execution of various standard laboratory techniques, including but not limited to H/UPLC, GC, water content analysis per USP, appearance assessment, water activity per USP, • May participate in qualification/verification of assays, • Assay and documentation review and report writing, • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices., • Execution of more advanced analytical techniques with assistance such as LC/MS, DSC, and TGA, • Independent preparation of samples, solutions, instrument set-up and breakdown, • Independent preparation of data packets and creation of stability data sheets and Certificates of Analysis to summarize analytical testing, • Assisted participation in Out of Specification investigations and the documentation of analytical deviations along with Qualified Investigators and management, • Understand and apply ICH and FDA guidance Basic Qualifications: • BS in Biology, Chemistry and/or related science discipline., • Computer literacy in Windows applications and the MS Office., • Excellent oral and written communication skills are essential., • Minimum of 3 years experience with HPLC, UPLC, GC, Karl Fisher, pH, • Maintain a safe working environment for all employees, ensuring compliance to all local, state, and federal codes and regulations. Preferred Qualifications: • Ability and willingness to work flexible hours., • Great attention to detail, quality, and a desire for success., • Self-motivated individual with the ability to learn, lead and strengthen the Beloteca, Inc. team.

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW We are seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members. KEY RESPONSIBILITIES (This list is not exhaustive and may be supplemented or adjusted as needed.) • Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets., • Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports., • Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures., • Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities., • Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions., • Lead P&ID walkdowns to verify installation, configuration, and system readiness., • Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes., • Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation., • Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets., • Provide technical mentorship and guidance to junior validation staff., • Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs. QUALIFICATIONS AND REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education • Bachelor's degree in a life science, engineering, or related technical field. Technical Experience • 7–11 years of experience in the biotech, pharmaceutical, or medical device industry., • Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles., • Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation., • Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation., • Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports., • Experience supporting audits, regulatory inspections, and remediation activities. Knowledge, Skills, and Abilities • Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences., • Highly organized with strong documentation and analytical skills., • Ability to lead validation workstreams, manage multiple priorities, and work independently., • Strong problem‑solving skills and experience supporting investigations and root‑cause analysis., • Ability to mentor junior engineers and contribute to team development. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $115,000 to $130,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross-functional development and execution of global regulatory labeling strategy. This individual will manage regulatory labeling through all phases of development and post-approval (end-to-end) ensuring that the latest requirements and standards are met. The ideal candidate will have experience collaborating with product and clinical development, medical, market access, and commercial stakeholders to generate phase and time-appropriate target product profile and labeling drafts, has successfully negotiated with health authorities, and global regulatory experience. Responsibilities • Collaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetings., • Lead development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements., • Provide expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles., • Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities., • Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents)., • Liaise with cross functional members and stakeholders to obtain input pertaining to labeling including resolution of key regulatory issues and labeling changes ., • Partner with Clinical Regulatory and cross-functional teams to support labeling supplements and updates, and health authority interactions related to labeling, • Ensure the dissemination of approved labeling documents and supporting documentation., • Maintain controlled records for all labeling changes and communicate labeling updates to stakeholders at the time of implementation., • Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise., • Participate in any relevant continuous improvement efforts for the end-to-end labeling process., • Monitor global regulatory environment and assess impact of changes on business and product labeling activities., • Facilitate policy development and updates with internal stakeholders. Requirements • Bachelor's degree in life sciences, computer science, or related science discipline, • Minimum 8+ in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas., • Knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling, • Experience leading cross-functional meetings and facilitating strategic discussions, such as negotiating with internal stakeholders and regulatory authorities on complex labeling issues., • Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistencies., • Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools), • Ability to maintain highest degree of professionalism, integrity and diplomacy Preferred • Experience with regulatory information management systems (e.g., Veeva RIM, Registrations)., • Knowledgeable in emerging technologies, including AI applications in regulatory operations., • Experience supporting global inspection readiness. California pay range $210,000—$240,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job Description Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs. Role Description: ADARx Pharmaceuticals is seeking an experienced, business-minded Sr. Corporate Securities Counsel to support the company's corporate governance, securities law compliance, strategic transactions, financing activities, and public company readiness. This role will partner closely with the Head of Legal, executive leadership, finance, investor relations, human resources, and external counsel to help ensure compliant, practical, and execution-oriented legal support for the company's growth strategy. The ideal candidate combines sophisticated law firm training with biotechnology or life sciences experience and is comfortable working across SEC reporting, disclosure controls, board governance, capital markets, equity compensation, and strategic business development transactions. Essential Responsibilities: • Securities and Capital Markets, • Support Securities Act and Exchange Act compliance activities, including public company readiness workstreams., • Prepare, review, and coordinate SEC filings, including registration statements, periodic reports, current reports, proxy statements, Section 16 filings, and equity plan registration statements., • Manage insider trading compliance, blackout procedures, Rule 10b5-1 plans, pre-clearance processes, and related employee communications., • Partner with finance and investor relations on disclosure review for earnings releases, investor presentations, analyst materials, press releases, and other external communications., • Support equity compensation matters, including equity plan administration, grant approvals, disclosure requirements, and employee education., • Corporate Governance, • Advise management and support the Board of Directors and committees on corporate governance matters, fiduciary duties, and governance best practices., • Prepare and maintain board and committee materials, agendas, resolutions, minutes, written consents, policies, charters, and corporate records., • Support annual shareholder meeting planning, D&O questionnaires, director and officer matters, and corporate secretarial functions., • Monitor evolving SEC, Nasdaq, Delaware corporate law, and governance requirements and translate developments into practical company actions., • Strategic Transactions, • Support business development and strategic transactions, including licensing and collaboration agreements, strategic alliances, equity investments, mergers and acquisitions, and other corporate transactions., • Coordinate legal due diligence, disclosure schedules, closing deliverables, internal approvals, and post-closing integration or compliance obligations., • Work with scientific, clinical, finance, business development, and executive teams to deliver practical legal advice aligned with transaction objectives., • Public Company Readiness and Compliance, • Help build and maintain public company legal infrastructure, including disclosure controls, committee processes, officer and director compliance calendars, and governance policies., • Provide trainings to executives, employees, and functional leaders on securities law, disclosure, insider trading, confidentiality, and public company expectations., • Manage outside counsel efficiently, including budgeting, work allocation, and quality control. Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • J.D. from an accredited law school and active membership in at least one U.S. state bar., • 8 to 10 years of relevant corporate, securities, capital markets, M&A, or governance experience, preferably with a combination of law firm and in-house experience., • Strong knowledge of the Securities Act of 1933, Securities Exchange Act of 1934, SEC reporting and disclosure requirements, corporate governance, and capital markets transactions., • Experience advising public and private companies on transactional, governance, and disclosure matters., • Excellent drafting, negotiation, project management, communication, and judgment skills. Preferred Experience: • Biotechnology, pharmaceutical, medical technology, or broader life sciences industry experience., • Experience supporting an IPO, public company transition, or public company compliance program., • Familiarity with Nasdaq-listed company requirements, Section 16, Rule 144, Regulation FD, Regulation S-K, Regulation S-X, and equity compensation disclosure., • Experience with licensing, collaboration, clinical development, or business development transactions in the life sciences sector., • Comfort operating in a fast-paced, pre-commercial or clinical-stage biotechnology environment. Core Competencies: Excellent judgment Practical, calibrated legal advice for senior leadership and directors. Securities expertise Strong command of SEC, Nasdaq, disclosure, and governance requirements. Transaction fluency Ability to support M&A, collaborations, licenses, financings, and diligence. Business partnership Collaborative style with finance, BD, clinical, HR, IR, and external counsel. Ownership mindset Can drive projects from issue spotting through execution and follow-through. Clear communication Concise drafting, crisp escalation, and strong cross-functional training skills. Compensation: • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • Paid Sick, Jury Duty, Bereavement Work Authorization: • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Director of IT Infrastructure is a leadership role responsible for the strategy, design, implementation, and ongoing operations of the company's enterprise IT infrastructure. This leader will oversee a geographically distributed environment spanning on-premises and public cloud platforms (Microsoft Azure and Amazon Web Services). The Director will lead a team of infrastructure staff to support business needs, drive modernization initiatives, and ensure the reliability and scalability of all infrastructure services in alignment with pharmaceutical industry standards. This role is based onsite 5 days a week from one of Arrowhead's office locations. Responsibilities • Define and execute a multi-year IT infrastructure roadmap aligned with corporate growth objectives and digital transformation priorities., • Lead, mentor, and develop a high-performing infrastructure team across multiple sites., • Partner with the IS leadership and business stakeholders to align infrastructure investments with organizational priorities and compliance requirements., • Establish and manage infrastructure budgets, vendor contracts, and technology refresh cycles., • Develop and communicate infrastructure KPIs, SLAs, and operational metrics to IS leadership., • Define and execute a multi-year IT infrastructure roadmap aligned with corporate growth objectives and digital transformation priorities., • Oversee the design, deployment, and lifecycle management of virtualization infrastructure across all company locations., • Manage a Microsoft Active Directory environment, • Drive hybrid cloud strategy and operations across Azure and AWS, optimizing workload placement, cost, and performance., • Ensure high availability, disaster recovery, and business continuity capabilities for all critical infrastructure components., • Oversee network infrastructure including LAN/WAN and SD-WAN connectivity across all company sites and cloud tenants., • Oversee server patching and configuration management standards across the enterprise., • Lead capacity planning and performance monitoring to ensure infrastructure scalability in support of business growth., • Ensure all infrastructure platforms and processes comply with regulatory requirements as applicable., • Support internal and external audits by providing documentation, evidence, and technical guidance related to infrastructure controls., • Maintain and test disaster recovery and incident response plans in partnership with IS and business teams., • Lead infrastructure-related projects from inception through delivery, including consolidations, cloud migrations, and site expansions., • Manage relationships with key technology vendors and MSPs, negotiating contracts and ensuring service delivery accountability., • Evaluate and recommend emerging technologies that drive operational efficiency and cost reduction. Requirements • Bachelor's degree in Computer Science, Information Systems, Information Technology, or a related field., • 10+ years of progressive IT infrastructure experience, with at least 4 years in a senior leadership or director-level role., • Deep hands-on expertise with virtualization platforms (VMware, Nutanix, Hyper-V)., • Demonstrated experience managing Microsoft Active Directory., • Strong working knowledge of AWS and Azure — architecture, operations, cost management, and security., • Experience managing multi-site enterprise IT environments in a regulated industry., • Proven track record of building, leading, and developing high-performing infrastructure teams., • Strong understanding of network architecture, security principles, and ITIL-based service management frameworks., • Experience with infrastructure compliance frameworks relevant to pharma/biotech (GxP, SOX, HIPAA). Preferred • Current or previous industry certifications such as VMware VCP/VCAP, Azure Administrator/Architect, AWS Solutions Architect, or ITIL v4., • Experience with infrastructure-as-code tools such as Terraform, Ansible, or Bicep., • Experience supporting laboratory and manufacturing IT environments (OT/IT convergence) within a pharmaceutical or life sciences setting., • Strategic thinking and the ability to translate business needs into scalable infrastructure solutions., • Strong communication skills - able to present complex technical topics clearly to non-technical audiences., • Exceptional organizational and prioritization skills in a fast-paced, regulated environment., • Collaborative leadership style with a strong emphasis on team development and cross-functional partnership., • Data-driven decision-making and a continuous improvement mindset. Wisconsin pay range $190,000—$210,000 USD California pay range $210,000—$230,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW We are seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members. KEY RESPONSIBILITIES (This list is not exhaustive and may be supplemented or adjusted as needed.) • Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets., • Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports., • Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures., • Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities., • Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions., • Lead P&ID walkdowns to verify installation, configuration, and system readiness., • Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes., • Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation., • Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets., • Provide technical mentorship and guidance to junior validation staff., • Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs. QUALIFICATIONS AND REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education • Bachelor's degree in a life science, engineering, or related technical field. Technical Experience • 7–11 years of experience in the biotech, pharmaceutical, or medical device industry., • Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles., • Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation., • Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation., • Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports., • Experience supporting audits, regulatory inspections, and remediation activities. Knowledge, Skills, and Abilities • Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences., • Highly organized with strong documentation and analytical skills., • Ability to lead validation workstreams, manage multiple priorities, and work independently., • Strong problem‑solving skills and experience supporting investigations and root‑cause analysis., • Ability to mentor junior engineers and contribute to team development. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $114,000 to $137,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job Description Job Title: Veterinary Research Scientist Primary Responsibilities: This position requires a broad knowledge of the anatomy and physiology of small and large animals to help develop and support in vivo models to screen therapeutics and devices being developed for various disorders. Experience with surgical, dosing and sampling techniques is required. In addition, the Veterinary Scientist is responsible for assisting in the clinical care of animals on surgical studies including post-operative monitoring and evaluations. Principal Duties and Responsibilities Perform surgical support and provide anesthesia, surgical, and analgesic technical expertise/advice to facilitate protocol development. Provide clinical and technical support to internal and external customers, regarding surgical models and services. Serve as the Research Lead or Study Director responsible for preclinical studies in various species. Assist in the preparation and review of study protocols and reports. Provide support for activities of the Institutional Animal Care and Use Committee (IACUC), including protocol review, program review, and facility inspections. Assist in activities to ensure the facility is in compliance with all applicable regulations, guidelines, and standards that relate to animal care and use. (USDA, FDA, and AALAC) Train staff on in-vivo procedures Make recommendations and assist in establishing and enhancing veterinary and animal care standards Will administer controlled substances and be responsible for maintaining appropriate records. May develop new or innovative surgical techniques or other procedural improvements appropriate to research studies. Perform special projects and assist with administrative efforts as needed. Candidate Requirements: Background in lab animal (in vivo) research with a focus on surgical techniques is a must. Ability to perform study duties and responsibilities in multiple species with minimal supervision. Must be flexible to work various schedules and hours as well as provide comprehensive, after hours, and on-call coverage as needed. This position requires good communication skills and attention to detail. Strong work ethic, self-motivation, and the ability to adapt to a dynamic team/work environment are keys to success. Education: Degree in veterinary medicine (BVM, DVM, or VMD) preferred. Graduate-level degree (M.S. or Ph.D.) in pharmaceutical science, life sciences, or pharmacology considered. Experience: Minimum 5-7 years of relevant industry experience depending on education level. Experience working with both small and large animals preferred. Working knowledge of imaging modalities (TEE, C-arm) will be a plus A comprehensive understanding of the requirements for GLP study execution and documentation is required.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Information Security Analyst II will join a team responsible for protecting both Operational Technology and Information Technology environments. This role combines enterprise security administration, and manufacturing security to ensure security, reliability and compliance of both business and production systems. The analyst is responsible for securing industrial control systems, manufacturing execution systems, distributed control systems, SCADA platforms, PLC-based automation systems, other manufacturing technologies, and enterprise endpoint environments. This role requires a self-directed professional who can manage security technologies, drive remediation efforts and partner with stakeholders. Responsibilities • Operational Technology, • Support cybersecurity initiatives for manufacturing and laboratory environments, including ICS, MES, DCS, SCADA, PLC, and connected operational systems., • Assist with OT asset inventory, vulnerability identification, risk assessment, and remediation planning., • Partner with Engineering and Manufacturing teams to implement security controls within production environments., • Participate in network segmentation, secure remote access, and industrial security architecture initiatives., • Support cybersecurity assessments of manufacturing technologies and third-party vendor solutions., • Monitor emerging threats impacting pharmaceutical manufacturing and industrial control environments., • Enterprise Security, • Design, implement, and maintain secure baselines, hardening standards, and compliance policies., • Monitor endpoint security posture and coordinate remediation of identified risks and vulnerabilities., • Evaluate and implement security controls to improve overall security posture., • Support threat detection, incident response, investigation, and remediation activities., • Perform security assessments and risk analysis of systems, applications, and infrastructure., • Develop and maintain security documentation, procedures, standards, and technical guidance. Requirements • Bachelor's degree in Information Security, Information Technology, Computer Science, Industrial Engineering or a related field, or equivalent combination of education and experience., • 3+ years of experience in Information Security, System Administration, Help Desk, or similar roles directly supporting OT, ICS, SCADA, or manufacturing environments., • Working knowledge of Purdue Enterprise Reference Architecture., • Familiarity with ISA/IEC 62443, NIST SP 800-82, NIST CSF 2.0, and CISA guidance for the critical manufacturing sector., • Ability to independently manage priorities and drive initiatives to completion., • Experience implementing endpoint security controls, system hardening, and configuration management practices., • Understanding of vulnerability management, incident response, and security monitoring processes., • Knowledge of Windows operating systems, Active Directory, Entra ID, and enterprise networking fundamentals. Preferred • Cybersecurity experience in OT, Industrial Control Systems, or manufacturing environment., • Experience with Dragos OT, Claroty Platform, Nozomi Networks, Defender for IoT, Fortinet OT Security, Tenable OT, Forescout Vistaro, Armis Centrix, etc. security., • Certifications relevant to security and compliance., • Hands-on experience with an OT-native detection platform., • Knowledge of industrial networking technologies., • Experience with historians and batch systems., • Prior participation in a regulatory inspection. Wisconsin pay range $80,000—$100,000 USD California pay range $88,000—$110,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the Chief Operating Officer, the Senior or Executive Director Quality Assurance GCP will lead GCP activities and have responsibility for strategic and tactical oversight and implementation of QA GCP operations in support of Erasca's clinical development programs (Phase 1, 2, 3), regulatory submissions, and planned future commercial launches. As a key member of the Quality Assurance leadership team, this person will partner with relevant clinical development and operations teams to execute GCP, GLP, GVP, and CDx strategies and participate in the further development of a high functioning Quality organization. Essential Duties and Responsibilities: • Ensure strategic and tactical clinical quality oversight of all Erasca clinical programs, • Provide seamless Quality oversight of global Ph3 trials and assure readiness for commercialization and launch, • Establish quality policies and procedures to ensure systems align with applicable GCP, GVP, and GLP global health authority regulations, guidance, and corporate policies, • Provide quality and compliance input and guidance to partners and stakeholders to achieve continuous quality improvement and effective quality controls, • Represent clinical QA on project and study teams, perform technical review of Clinical Study Documents and provide QA guidance on quality compliance issues, regulatory risk, and process improvements, • Develop a risk-based GCP audit program and compliance strategy for Erasca clinical study programs, • Prepare and lead GCP and GVP inspection; eventually hire, develop, and mentor QA Audit and Clinical Inspections staff, • Manage external GCP auditors, support timely review of audit reports, and communicate findings to auditees, cross-functional representatives, and management. Ensure corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate, • Support global regulatory, due diligence, and partner inspections including preparing sites and training staff on regulatory inspection management best practices, • Represent Clinical Quality during global regulatory inspections at Erasca including supporting regulatory inspections at global clinical sites for Erasca clinical studies, • Work with Clinical Operations to oversee study documentation, including TMF, for accuracy and inspection readiness, • Perform quality reviews of Clinical Study Documents with a focus on compliance, regulatory requirements, and risk assessment. The study documents include but are not limited to: Study Protocols, ICFs, Annual Reports (e.g., DSUR), other subject-facing documents (brochures, recruitment materials), Investigator's Brochure, and CSR, • In collaboration with function heads, ensure GCP, GVP, GLP, and CDx vendors comply with applicable quality programs and regulations or guidelines and are prepared for Regulatory inspections, • Align with GMP Quality Assurance and Quality Systems on the development and optimization of the quality infrastructure, systems, and policies to ensure continuity within quality operations, • Collaborate with Development, Research, and Quality Assurance colleagues to establish quality metrics and assess the state of GCP, GVP, GLP, and CDx Quality compliance across Erasca clinical studies., • Compile, track, and analyze GCP quality KPIs and vendor performance for all Erasca-initiated clinical studies, and prepare quarterly reports for quality management, • Conduct gap analysis and risk assessment for critical study level activities that may impact subject safety and/or the quality and reliability of data, including but not limited to: Study Design and Protocol Requirements, Clinical Vendors and Service Providers-Transferred Obligations, contractual duties per SOW, and overall performance, Internal processes (e.g., vendor oversight), and Clinical Site and PI assessment and performance., • Escalate quality events, IPDs, potential serious breaches to relevant leadership as needed and in a timely manner including initiating CAPAs and CIs to address major findings and gaps., • Lead, manage, develop, and mentor direct reports, • Perform all duties in keeping with the Company's core values, policies, and all applicable regulations Required Education and Experience: • Undergraduate degree in Biology, Chemistry, Physical Sciences, or related discipline preferred, • 12+ years of experience including management of GCP Quality in a pharmaceutical or biotech environment in progressively responsible Quality roles required, • Experience with quality for registrational clinical trials required; transition from clinical stage to commercial quality systems highly preferred, • Experience with the application of phase-appropriate quality systems across the product development lifecycle and on to commercial launch highly preferred, • Experience in regulatory inspections required, experience interacting with global regulatory agencies through the drug product approval process preferred, • Extensive experience participating in regulatory agency inspections of global clinical research activities, • Deep expertise in GCP Quality required, oversight of GVP, GLP, and CDx activities preferred, • Extensive knowledge of ICH GCP (E6) and other relevant ICH guidelines (including E8, E2F, and E3), as well as FDA, EMA, Health Canada (HC), PMDA, and other global regulatory requirements governing drug development, with demonstrated application of GCP and GLP principles in clinical research, • Must have excellent written and verbal communication skills with the ability to tailor communication to all levels and prepare and present appropriate updates to functional groups and leaders, • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment, • Excellent interpersonal and influencing skills, • Strong learning orientation, curiosity, and commitment to science and patients The anticipated salary range for this position is $250,000 - $290,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job Description ABOUT IMMUNEERING Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture. The Associate Director, Formulation Development will be responsible for overseeing all aspects of Immuneering’s drug product development program, from candidate nomination through the clinical development stage of product lifecycle. This entails the conduct of pre-formulation studies, formulation development, tech transfer, scale-up and manufacturing. This position requires experience in solid oral dosage formulation development, including enabling formulations for poorly soluble (BCS Class II/IV) compounds, and API form characterization and selection. This position also requires a thorough understanding of the principles of quality by design (QbD), and extensive experience in scientific technical writing for drug development and regulatory submissions. Prior experience managing drug product process development and manufacture at CROs and CDMOs is also critical for this position. The successful candidate will be a highly motivated, proactive team player with a strong background in formulation science and process development, and a proven track record of accomplishments. This position will report to the Head of CMC. Job Functions and Responsibilities • Conduct pre-formulation studies, including API form characterization and selection, in collaboration with Process Chemistry, • Design, execute, and interpret formulation screening and excipient selection studies, • Define phase-appropriate formulation approaches that balance clinical needs, manufacturability, regulatory expectations, and commercial considerations, • Develop innovative, robust, efficient, scalable and cost-effective drug product manufacturing processes, • Act as the main point of contact directing drug product manufacturing process development, technology transfer and manufacturing campaigns at external CDMOs, including development, review and approval of process development protocols, master batch records and manufacturing campaign reports, • Provide person-in-plant support for drug product manufacturing campaigns as required, • Review and approve executed batch records, and provide technical review and approval for quality investigations and batch disposition records, • Assist in establishing critical quality attributes and critical process parameters for drug products in development, • Author or review development reports and risk assessments, • Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies, • Serve as drug product SME for cross-functional project teams, • Collaborate within CMC and across the wider development team to deliver quality drug product for clinical trials within required timelines • Serve as a technical expert and keep current in the field of formulation and process development, • Work in compliance with cGMP, safety and regulatory requirements, • Champion a strong winning culture through the relentless pursuit of excellence, fostering a collaborative and collegial approach to teamwork, and a first-in-class quality organization Education, Skills and Qualifications Required: • PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 8+ years of industry experience; or MS or BS degree in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 12+ years of industry experience, • A foundational understanding of pre-formulation studies, formulation design and development and drug product manufacturing process development, • Experience in formulation development of poorly soluble (BCS Class II/IV) compounds (e.g., amorphous solid dispersions (spray-dried dispersions, hot-melt extrusions), lipid-based and self-emulsifying formulations (SEDDS, SMEDDS, lipid suspensions, LNPs, SLNs), micro-encapsulation, micro/nano formulations (nanocrystals, nanosuspensions), salt formulations, co-crystals, etc.), • Experience in drug product technology transfer and manufacture, • Experience managing CDMOs for research, development and manufacturing campaigns, • Solid understanding of relevant FDA, EMA, and ICH regulatory guidelines as applicable to drug product manufacturing, and current standards of practice in the industry, • Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies, • A critical and strategic thinker with exceptional decision-making skills and the ability to work independently in a fast-paced, high-pressure setting, • Excellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions, • Values-based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture Preferred • Strong theoretical and practical background in relevant pharmaceutical technologies such as dry/wet granulation, extrusion, spray drying, tableting and coating, • Fundamental understanding of physicochemical and biopharmaceutical properties as related to formulation design, • Application of QbD principles to the drug development process, including experience in developing quality target product profiles (QTPPs), defining critical quality attributes (CQAs) and critical material attributes (CMAs), and determining critical process parameters (CPPs) using failure mode and effects analysis (FMEA) and other risk assessment tools • Expertise in pediatric formulation development, • Thorough understanding of analytical techniques used for API form characterization and selection and pre-formulation studies including HPLC, LC-MS, XRPD, DSC, Dissolution, and KF, • Experience in IND/IMPD and NDA/MAA submissions, • Experience in managing quality investigations, • Self-motivated, detail-oriented, with a continuous quality improvement mindset, high personal integrity, and excellent time management and organizational skills, • Excellent communication, problem-solving and organizational skills; thrives in a cross-functional team environment Additional Information • Travel: 10 to 20%, • Location: Remote EQUAL OPPORTUNITY EMPLOYER Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

Job DescriptionDescription: The Manager, GMP Quality Operations is responsible for day-to-day Quality oversight of GMP manufacturing and testing activities across Viking’s external manufacturing network, supporting late-stage clinical development and future commercial programs. The Manager will work closely with Viking Quality, Technical Operations/CMC, Regulatory Affairs, Supply Chain, and external CDMOs to ensure manufacturing, testing, and release activities are executed in compliance with cGMP requirements, Quality Agreements, and Viking quality standards. This role will provide hands-on Quality Operations support across drug substance, drug product, and combination-product manufacturing activities, including batch record review and disposition, deviation and investigation management, change control, technology transfer, process validation/PPQ, and inspection readiness. This is an onsite role based in San Diego, CA, with periodic travel to domestic and international CDMOs as required. Travel: ~25% Essentials Duties and Responsibilities The main responsibilities of this role include: • Manage external Quality Operations activities in support of GMP manufacturing for clinical and future commercial programs., • Manage deviations, OOS/OOT investigations, and CAPAs in accordance with cGMP requirements and ICH guidelines., • Review and approve GMP documentation, including batch records, analytical and technical reports, and Quality/CMC documentation supporting regulatory submissions (e.g., IND/IMPD and NDA/MAA)., • Provide QA support for technology transfer and process validation activities., • Perform disposition of GMP batches and interface with Qualified Persons (QPs) and CDMO Quality organizations to support product release., • Manage change controls to ensure appropriate evaluation of manufacturing- and testing-related changes by Quality, Regulatory Affairs, and relevant subject matter experts., • Support management of CDMO quality performance in accordance with Quality Agreements and GMP requirements., • Drive continuous improvement and inspection readiness activities., • Collaborate cross-functionally to support pre-approval inspection and commercial readiness activities at CDMOs., • Participate in compliance discussions and support the resolution of quality issues and implementation of required corrective actions., • Foster a culture of collaboration, accountability, and operational excellence across internal and external teams., • Perform additional tasks as assigned Requirements: Education and Experience Requirements • Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related discipline., • 7+ years of progressive experience in GMP Quality Operations within pharmaceutical or biotechnology organizations. Knowledge and Skills Requirements • Hands-on experience supporting external manufacturing/CDMO operations strongly preferred., • Experience supporting late-stage clinical development and/or commercial manufacturing environments preferred., • Demonstrated experience with GMP batch record review, investigations, deviations, CAPA, change control, and product disposition., • Experience with technology transfer, process validation/PPQ, and manufacturing scale-up activities preferred., • Experience with small-molecule drug substance and/or drug product manufacturing., • Experience with one or more of the following is highly desirable: Sterile injectable manufacturing, including prefilled syringes and vials, Solid oral dosage forms, Drug-device combination products, including autoinjectors, • Experience interfacing with Qualified Persons (QPs) and/or global product-release functions is desirable., • Working knowledge of applicable global GMP regulations and guidance, including FDA, EMA, and ICH requirements., • Strong ability to review complex GMP documentation and identify quality, compliance, and product-impact risks., • Demonstrated ability to work effectively with external CDMOs and cross-functional internal teams without direct authority., • Strong organizational and project-management skills with the ability to manage multiple priorities and meet aggressive timelines., • Excellent written and verbal communication skills and the ability to communicate and escalate quality risks effectively. VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. #LI-DNI Salary Description $110,000.00 - $135,000.00 annual salary

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world's largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. - Compass Pathways Job overview: The Site of Care Account Lead (SOC-AL) is responsible for developing, managing, and supporting strategic relationships with priority Organized Care Groups (OCG) - Interventional Psychiatry Clinics, Health Systems, and Integrated Delivery Networks (IDN) that will serve as early adopters of COMP360 psilocybin therapy. This role focuses on account level strategy, operational readiness, and cross‑functional coordination to ensure sites of care have the infrastructure, training, and support needed to deliver high-quality psilocybin treatment. The SOC-AL partners closely with Sales, Marketing, Patient Engagement, Medical Affairs, Market Access, and Clinical Operations to build a scalable, sustainable ecosystem for COMP360 therapy. Location: Field-based in the West region (Southern California, Oregon, Washington) and able to travel ~70% within region via plane, train, or car. Reports to: Director, Site of Care Marketing. Roles and responsibilities (Include but are not limited to): Account Strategy & Development • Identify, prioritize, and manage relationships with high potential OCGs inclusive of Interventional Psychiatry Clinics, IDNs, health systems, and behavioral health networks, • Develop, execute, and maintain account-level business plans aimed at long term growth and joint value creation based on each OCGs operational, clinical, and strategic needs, • Guide accounts through the stages of COMP360 readiness - from initial interest to full operational capability, • Assess site capabilities, infrastructure, staffing, and training needs to support safe and effective therapy delivery Operational Readiness & Implementation Support • Support sites in understanding and preparing for COMP360 psilocybin therapy workflows and help accounts navigate logistical requirements, • Identify operational barriers and collaborate internally to develop solutions, resources, or process improvements, • Track progress toward readiness milestones and ensure timely execution of implementation plans, • Deliver or coordinate educational sessions on COMP360 therapy, site of care models, and operational best practices, • Ensure accounts have access to Compass approved materials and implementation resources, • Support Compass's presence at conferences, workshops, and site of care events by engaging with Qualified Audiences Relationship Management & Engagement • Serve as the primary point of contact for prioritized OCGs, ensuring consistent communication and high-quality support, • Build strong relationships with Qualified Audience including – population -based clinical decision makers, administrators, operational directors, and financial decisionmakers (those developing/operationalizing care pathways), • Facilitate introductions and engagements with internal Compass Matrix teams (Patient Engagement, Medical Affairs, Sales, Market access) for functional expertise Insights & Business Planning • Develop and maintain account level business plans for target OCGs, • Provide regular and routine business plan updates to leadership and Matrix colleagues, • Gather account level insights on operational challenges, adoption drivers, reimbursement considerations, and competitive dynamics., • Provide structured feedback to Site of Care Marketing and Matrix team to inform ecosystem planning, • Monitor policy, regulatory, and payer developments that may impact account strategy Cross‑Functional Collaboration • Coordinate with Medical Affairs for appropriate scientific clinical exchange and education, • Collaborate with Patient Engagement to support REMS certification and reimbursement readiness, • Coordinate with Market Access to support payer-related discussions, • Coordinate with Marketing to refine messaging, tools, and resources based on account feedback, • Coordinate with Sales colleagues to engage with prescribing HCPs upon OCGs headquarter approval of individual site operational preparedness Candidate Profile: Required • Bachelor's degree in business, healthcare administration, life sciences, or related field, • 8+ years of experience in pharmaceutical or biotech managing strategic healthcare accounts, provider networks, health systems, specialty practices, integrated delivery networks (IDNs), or specialty pharmacy stakeholders in provider-facing healthcare services, • Strong understanding of behavioral‑health delivery, practice development, specialty‑care operations, or novel‑therapy implementation, • Demonstrated ability to manage complex accounts with multiple stakeholders, • Excellent communication, negotiation, and relationship building skills, • Ability to navigate complex healthcare organizations and coordinate stakeholders across clinical, pharmacy, finance, compliance, and operations functions Preferred • Experience in mental healthcare, neuroscience, or psychedelic assisted therapy, • Background in launching or scaling innovative care models or REMS monitored specialty therapeutics, • Familiarity with reimbursement pathways, payer dynamics, and health‑system economics, • Experience supporting launch or expansion of specialty pharmaceutical products requiring complex site-of-care readiness and patient access pathways Success Measures • Development and execution of annual strategic account plans for priority accounts, • Percentage of targeted accounts successfully completed launch readiness assessments within projected timelines, • Average time of progression from account identification through readiness milestones, • Strength and depth of relationships with key decisionmakers at strategic sites based on account engagement scores or stakeholder satisfaction ratings, • Quality and actionability of account insights delivered to internal teams, • Contribution to the scalability and consistency of the site of care model, • Alignment of account activities with broader commercial and medical strategy Compensation Description (annually): Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. 【Base salary per annum】: $180,000—$215,000 USD Benefits: For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits". These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health. Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description The Clinical Trial Associate (CTA) will provide operational support for the planning, execution, and closeout of clinical studies across Janux Therapeutics' clinical development programs. The CTA will partner closely with Clinical Trial Managers, Clinical Operations leadership, CROs, study vendors, and investigative sites to ensure studies are conducted in compliance with protocol requirements, ICH/GCP guidelines, regulatory requirements, and internal SOPs. This individual will be responsible for coordinating study documentation, maintaining inspection-ready Trial Master Files (TMFs), tracking study metrics, supporting study start-up and closeout activities, and facilitating communication among cross-functional stakeholders. The ideal candidate is highly organized, detail-oriented, proactive, and eager to grow within a fast-paced biotech environment. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Support the day-to-day execution of clinical trials from study start-up through closeout., • Assist Clinical Trial Managers with operational study activities and project coordination., • Coordinate study team meetings, prepare agendas, document meeting minutes, and ensure follow-up on action items., • Maintain study trackers, timelines, enrollment reports, and operational dashboards., • Assist with site onboarding and activation activities., • Support management of CROs, vendors, and study-related deliverables., • Maintain electronic Trial Master Files (eTMFs) to ensure completeness, quality, and inspection readiness., • Conduct routine TMF reviews and reconcile missing or incomplete documents with CROs and study vendors., • Assist with collection, review, filing, and archiving of essential trial documents., • Maintain study-specific filing systems and operational documentation., • Support study start-up activities including vendor onboarding, site activation, investigator meetings, and study system setup., • Assist with review and distribution of study materials, informed consent documents, and study tools., • Coordinate clinical trial supplies, equipment shipments, and study-related materials., • Track regulatory submissions, site essential documents, and study milestones., • Serve as an operational point of contact for clinical sites, CROs, and other external partners., • Facilitate communication between internal teams and external stakeholders., • Track site and vendor inquiries and route issues to appropriate team members., • Assist with scheduling vendor meetings and maintaining documentation of vendor performance activities., • Ensure clinical trial activities are conducted in accordance with ICH/GCP guidelines, applicable regulations, and internal SOPs., • Support audit and inspection readiness activities., • Assist with quality review of study documentation and study-level processes., • Participate in process improvement initiatives across Clinical Operations., • Support study closeout activities, including TMF reconciliation, site document collection, and archiving activities., • Assist with drug accountability reconciliation and study documentation required for Clinical Study Reports (CSRs)., • Perform other duties as assigned.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor's degree in Life Sciences, Nursing, Public Health, or a related scientific discipline., • 2+ years of clinical research experience in a pharmaceutical or biotechnology setting., • Experience supporting Phase I-IV clinical trials., • Experience supporting autoimmune, immunology, or oncology clinical trials preferred., • Working knowledge of ICH/GCP guidelines and applicable clinical research regulations., • Experience maintaining clinical trial documentation and/or Trial Master Files (TMFs)., • Familiarity with clinical systems such as eTMF, CTMS, EDC, IRT, or related platforms., • Strong organizational skills and exceptional attention to detail., • Excellent written and verbal communication skills., • Ability to manage multiple priorities in a fast-paced environment., • Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook., • Demonstrated ability to work collaboratively across cross-functional teams., • Ability to work independently in a fast-paced environment while appropriately escalating issues., • Minimal travel required (0-10%). In addition to a competitive base salary ranging from $105,000 to $115,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity. Job Type: Full-time Benefits: · Annual bonus program · Incentive stock option plan · 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance · HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule: · Monday to Friday Work authorization: · United States (Required) Additional Compensation: · Annual targeted bonus % Work Location: · Onsite in our San Diego office preferred; hybrid arrangements may be considered with approval and require a minimum of three days per week onsite. EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party Agencies The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. Salary range and description Application questions Standard Application Questions • Are you 18 years of age or older?, • Do you have proof of right to work in the United States?, • Will you now or in the future require Visa sponsorship?, • Are you able to relocate to San Diego and/or report in office 5 days per week?, • (Hybrid jobs ONLY) If you are not able to relocate and/or report to office daily, are you willing to travel to San Diego on a monthly basis or as needed?, • Please note your desired compensation (refer to job post for the salary range), • Please note your desired pronoun Distributions: all applications Clinical Scientist Questions, • Which therapeutic areas do you have experience in, and approximately how many years have you worked in each?, • What phases of clinical studies do you carry experience in?, • Which clinical and regulatory documents have you worked on, and what was your role in their preparation? Distributions: all applications We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description About Avalyn: Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn's AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn's AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn. Position Overview: The Senior Scientist, Formulation Development will play a key role in advancing Avalyn's pipeline of inhaled therapies for pulmonary fibrosis. This position will focus on the development and optimization of solution and dry powder formulations, aerosol performance, and drug-device compatibility to support clinical development, process scale-up, and future commercial manufacturing. This is a hands-on laboratory position focused on formulation development for inhaled therapeutics. The successful candidate will possess deep expertise in formulation development, aerosol science and pulmonary drug delivery and will apply scientific knowledge to develop robust product candidates that support clinical and commercial development. The Senior Scientist will collaborate closely with Pre-Clinical Development, Analytical Development, Manufacturing, Regulatory Affairs, Quality, and other partners to advance inhaled drug products from early development through late-stage clinical development. This position is based in San Diego, California and reports directly to the SVP of Product Development. Key Responsibilities: Formulation Development • Design, execute, and document laboratory studies supporting development of inhaled drug products., • Develop and optimize solution and dry powder formulations for pulmonary drug delivery., • Design formulation screening studies to improve product performance, manufacturability, and stability., • Conduct preformulation studies, including pH-solubility, temperature-solubility, excipient compatibility, pH-kinetic, and related characterization studies to inform formulation design and development., • Evaluate excipients, formulation composition, and processing parameters to optimize aerosol performance., • Apply Design of Experiments (DoE) methodologies to support formulation optimization., • Support formulation selection for clinical development. Aerosol Science & Characterization • Perform and interpret aerosol characterization studies using standard inhalation testing methodologies., • Evaluate aerodynamic particle size distribution (APSD), emitted dose, delivered dose uniformity, and fine particle fraction., • Conduct aerosol performance testing of dry powder formulations and characterize dry powder formulation attributes to support formulation optimization and product development., • Analyze aerosol performance data and recommend formulation improvements., • Assess formulation-device compatibility and performance., • Troubleshoot formulation and aerosol performance issues using scientific investigation and laboratory experimentation. Laboratory Operations • Maintain detailed laboratory notebooks and technical documentation in accordance with company procedures., • Analyze experimental data and prepare technical reports, presentations, and development summaries., • Ensure laboratory activities are conducted in compliance with applicable quality and safety requirements., • Maintain laboratory equipment and coordinate analytical testing as required., • Assist in hiring, onboarding, and managing a laboratory technician to execute formulation development, preformulation, aerosol testing, and characterization studies. Product Development • Collaborate with cross-functional development teams to advance inhaled drug products through clinical development., • Support technology transfer activities to manufacturing sites and CDMOs., • Participate in process development, scale-up activities, engineering batches, and clinical manufacturing campaigns., • Support CMC documentation for regulatory submissions, including INDs, IMPDs, briefing documents, and other technical reports. Technical Leadership • Provide scientific expertise in formulation development and aerosol science across Product Development., • Stay current with advances in inhalation technologies and pharmaceutical formulation science., • Present technical findings to project teams and senior management. Qualifications: • Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Materials Science, or a related scientific discipline is required., • A minimum of 8 plus years of industry experience in pharmaceutical formulation development following completion of a Ph.D. is required., • Experience developing inhaled pharmaceutical products is highly preferred., • Deep understanding of aerosol science and pulmonary drug delivery is preferred., • Hands-on experience with solution and dry powder inhalation formulations is desirable, • Experience working with inhalation devices and drug-device combination products is preferred, • Strong understanding of formulation characterization techniques, aerosol performance testing, and stability studies is required., • Experience working with CDMOs and supporting technology transfer is required., • Demonstrated ability to work independently, take ownership of formulation development activities, and exercise sound scientific judgment., • Demonstrated ability to work effectively on cross-functional teams., • Knowledgeable about applicable GMP regulations and quality expectations relevant to pharmaceutical development and laboratory operations., • Experience supporting products through IND-enabling activities, clinical development, and commercialization is preferred., • Knowledge of regulatory expectations for inhalation products is preferred., • Experience with spray drying, particle engineering, or advanced formulation technologies., • Familiarity with Quality by Design (QbD) principles and pharmaceutical development best practices. Proposed pay range $150,000—$162,000 USD

Job Description The Senior Manager, Clinical Contracts will ensure the successful negotiation and ongoing management of clinical trial-related agreements and serve as the key liaison between Clinical Operations, Legal, Finance and Accounting departments. This role involves but is not limited to generating, reviewing, finalizing and tracking contracts and budgets, and managing cross-functional communication. This individual will be expected to support the clinical team in the planning, execution and control of contracts. The ideal candidate tasks effectively and applies critical thinking to resolve challenges while maintaining clear communication. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Provide comprehensive contract lifecycle management., • Work closely with Clinical Operations, Legal, Finance, and other internal and external stakeholders to support the timely initiation, contractual term review, negotiation, risk assessment, execution and administration or contracts., • Manage tracking of contracts, amendments and budgets, and provide updates to the project and cross-functional teams., • Serve as point person for contracts with internal and external stakeholders., • Support RFx and Vendor Management activities., • Support internal oversight of site payment management., • Establish contracting SOPs and guidance documents., • Active participation in team meetings for the purpose of expediting contracts to execution., • Build and maintain strong relationships with external customers, investigators, and vendors., • Facilitate contract actions and processes independently and effectively in a dynamic environment with competing priorities., • Respond promptly and professionally to inquiries from internal team members and external vendors., • Strong analytical and contract administration skills, verbal and written communication skills., • Identify and implement process improvements to enhance efficiency and accountability., • Ensure compliance with SOPs and regulatory guidelines, addressing QA and audit requests as needed.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Bachelor’s degree required., • 8+ years of contract management experience within the biotechnology or pharmaceutical industry preferred. Experience within academia or a Clinical Research Organization (CRO) may also be considered based on the overall strength and relevance of the candidate's background., • Clinical Site Budget experience necessary., • Strong experience with global Phase 1-3 clinical trials. Oncology clinical trial experience preferred., • Grant Plan experience a plus., • Good knowledge of ICH-GCP, pharmaceutical related regulations and laws., • Ability to thrive in a fast-paced growing company with minimal direction and ability to adjust to changing priorities., • Proficiency in Microsoft Excel at an Intermediate level required. In addition to a competitive base salary ranging from $170,000 to $182,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location. Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution· Comprehensive medical insurance with 90-100% employer-paid premiums· Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)· Unlimited PTO· Generous holiday schedule; includes summer and winter company shutdown· Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· Onsite in our San Diego office preferred; hybrid arrangements may be considered with approval and require a minimum of three days per week onsite. EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.Salary range and description Application questionsStandard Application Questions • Are you 18 years of age or older?, • Do you have proof of right to work in the United States?, • Will you now or in the future require Visa sponsorship?, • Are you able to relocate to San Diego and/or report in office 5 days per week?, • (Hybrid jobs ONLY) If you are not able to relocate and/or report to office daily, are you willing to travel to San Diego on a monthly basis or as needed?, • Please note your desired compensation (refer to job post for the salary range), • Please note your desired pronounDistributions: all applicationsClinical Scientist Questions, • Which therapeutic areas do you have experience in, and approximately how many years have you worked in each?, • What phases of clinical studies do you carry experience in?, • Which clinical and regulatory documents have you worked on, and what was your role in their preparation?Distributions: all applications We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description About BlossomHill Therapeutics: BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors. For more information visit BlossomHill Therapeutics. Job Summary The Senior Manager, Drug Safety will play a key role in supporting the company’s drug safety and pharmacovigilance activities. This hands-on role will provide clinical, scientific, and operational expertise in the identification, assessment, documentation, and management of safety information arising from clinical trials. The successful candidate will have progressive, hands-on drug safety/pharmacovigilance experience and a strong understanding of clinical safety principles, global regulatory requirements, safety surveillance, and outsourced pharmacovigilance operations. The role will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Data Management, and other cross-functional teams to ensure timely, compliant, and high-quality safety assessment and reporting. The ideal candidate will bring a clinical background, with a nursing degree preferred, combined with hands-on experience in drug safety and the ability to work effectively in a dynamic, development-stage oncology environment. This is an onsite role based in our San Diego office. Key Responsibilities • Support and provide clinical expertise across drug safety and pharmacovigilance activities for oncology clinical development programs., • Manage end-to-end SAE operations, including CRO management for case intake, triage, case review, follow-up, regulatory reporting, clinical database reconciliation, escalation, and closure of safety information., • Oversee case processing activities, including MedDRA coding, narrative development, quality control, medical review workflow, case distribution, and compliance with applicable reporting timelines and procedures., • Contribute to the submission of expedited safety reports, DSURs and other aggregate reports, and related pharmacovigilance deliverables., • Support clinical trial safety activities, including review of aggregate safety data, safety listings, relevant safety analyses, and clinical trial safety documentation., • Collaborate with Clinical Development and Clinical Operations on safety-related aspects of clinical trials, including SAE review, safety data reconciliation, and ongoing benefit-risk assessment., • Contribute to the development and maintenance of safety-related processes, procedures, work instructions, and safety management plans., • Support safety input into clinical study protocols, informed consent documents, investigator materials, and other clinical development documents as appropriate., • Participate in cross-functional safety review meetings and communicate clinically relevant safety findings and recommendations to internal stakeholders., • Provide day-to-day oversight of external pharmacovigilance vendors/CROs, including work allocation, case quality and timeliness, reconciliations, issue escalation, performance metrics, and compliance with safety data exchange agreements and company procedures., • Ensure drug safety activities are conducted in accordance with applicable company procedures, ICH guidelines, FDA regulations, and global pharmacovigilance requirements., • Support inspection readiness and contribute to responses to regulatory inquiries related to drug safety and pharmacovigilance., • Assist with the preparation and review of safety-related documentation for regulatory submissions., • Contribute to continuous improvement of pharmacovigilance processes, systems, and quality practices as the company and its oncology portfolio evolve. Qualifications • Bachelor’s degree in Nursing preferred., • Minimum of 6 years of progressively responsible experience in drug safety/pharmacovigilance within the pharmaceutical, biotechnology, or CRO environment, including substantial hands-on clinical-trial safety operations experience., • Required experience includes:, • End-to-end ICSR processing and medical/clinical review, including seriousness, expectedness, causality, MedDRA coding, narrative review, follow-up, quality control, and case closure, • SAE management for interventional clinical trials, including clinical database-to-safety database reconciliation and resolution of data discrepancies, • Preparation and review of expedited reports and aggregate safety deliverables, including DSURs; experience supporting safety sections of investigator brochures and regulatory submissions is preferred, • Direct oversight of pharmacovigilance vendors/CROs, including case quality, timeliness, KPIs, issue management, reconciliations, and inspection-ready documentation, • Use of a validated global safety database, preferably Oracle Argus, and familiarity with EDC systems and safety data transfer/reconciliation processes, • Development or implementation of pharmacovigilance SOPs, work instructions, safety management plans, and safety data exchange agreements, • Ongoing safety surveillance, review of aggregate safety data and listings, signal identification, and communication of clinically meaningful findings to cross-functional stakeholders, • Working knowledge of ICH and FDA safety/pharmacovigilance regulations and guidelines; familiarity with global regulatory requirements is a plus., • Knowledge of MedDRA coding and terminology., • Demonstrated proficiency with pharmacovigilance/safety databases, preferably Oracle Argus; experience with EDC systems and safety reporting tools is highly desirable., • Strong clinical judgment and the ability to evaluate complex safety information and communicate its significance clearly., • Excellent written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams., • Strong attention to detail, organizational skills, and ability to manage multiple priorities and deliverables in a deadline-driven environment., • Ability to work independently while also contributing effectively within a collaborative, cross-functional team., • At least 2 years of oncology drug-safety or oncology clinical-development experience is strongly preferred, particularly in early-phase clinical trials., • Experience working in a biotechnology or emerging pharmaceutical company environment is a plus. Equal Employment Opportunity: The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Recruiters and Agencies: BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHill employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired. E-Verify: BlossomHill Therapeutics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) to resolve the issue.

Job Description The Senior/Clinical Trial Manager will be responsible for managing and executing operational aspects of assigned clinical trials, from study start-up to close-out, with a focus on autoimmune studies. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Senior Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Support the successful execution of clinical trials from protocol concept to clinical study report in support of complex autoimmune programs., • Prepare and maintain study-related files and documentation to ensure inspection readiness., • Organize and lead study and departmental meetings, including minute-taking and document archiving., • Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings)., • Ensure team compliance with study-specific training and perform TMF reviews for completeness., • Support clinical sites in preparation for audits and inspections., • Assist with budget management and day-to-day clinical operations in compliance with SOPs, ICH/GCP, and regulatory requirements., • Track subject and site activity/metrics and perform quality checks across study components., • Proactively identify and escalate issues related to functional deliverables., • Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation., • Collaborate with CROs to ensure timely collection and archiving of TMF documents., • Coordinate with regulatory affairs on essential document submissions., • Support study close-out activities including TMF and drug reconciliation and CSR readiness., • Communicate effectively with study team members and work closely with Clinical Trial Managers and/or Asset Leads., • Participate in process improvement and quality initiatives related to study execution., • Other duties as deemed necessary.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor’s degree with at least 5 years (CTM) or 8 years (Sr. CTM) of hands-on clinical trial experience, preferably within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered., • Demonstrated experience in complex autoimmune clinical trials, including trial set-up, monitoring, and close-out., • Strong working knowledge of ICH/GCP regulations., • Proficiency with electronic systems such as eTMF, CTMS, EDC, etc., • Ability to work independently with minimal oversight and thrive in a collaborative team environment., • Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset., • Excellent interpersonal, written, and verbal communication skills., • Proficiency in MS Office and comfort with technology., • Minimal travel required (0 to 5%). In addition to a competitive base salary ranging from $140,000 to $154,000 for Clinical Trial Manager and $160,000 to $178,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity. Job Type: Full-time Benefits: • Annual bonus program, • Incentive stock option plan, • 401k plan with flat non-elective employer contribution, • Comprehensive medical insurance with 90-100% employer-paid premiums, • Dental and vision insurance, • HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity), • Unlimited PTO, • Generous holiday schedule; includes summer and winter company shutdown, • Relocation assistance Schedule: • Monday to Friday Work authorization: • United States (Required) Additional Compensation: • Annual targeted bonus % Work Location: • Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel 25% for meetings or site visits as required. EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Title: Sr. Scientist Location: San Diego, CA ( Onsite) Duration: 8 Months W2 contract with high possibility of extension based on performance and depending on business needs Shift: Monday – Friday ( Standard Shift) Pay Range: $40 - $43/hr. on W2(All inclusive) Job Summary: We are seeking a highly motivated Scientist to join our Pharmaceutical Development team. This role will contribute to laboratory-based biologics drug product development by executing assigned studies and, as experience permits, planning and leading smaller defined work items under general to broad supervision. The role will support instrument setup and laboratory capability, phase-appropriate formulation and drug product process development, and physicochemical/bioanalytical characterization using state-of-the-art methods and equipment, including but not limited to UPLC or HPLC (SEC, RP, HIC, IEX/CEX, CAD preferred), charge variant analysis, particle analysis, CE-SDS, and other physical-property characterization. The successful candidate will collaborate with internal and external partners, communicate results and recommendations, and flexibly support multiple development projects in a fast-paced team environment. Experience with LC and iCiEF is required. Responsibilities: • Contribute to the setup, operation, maintenance, and routine troubleshooting of laboratory instruments; support method development and draft related procedures, reports, SOPs, and best-practice documentation., • Independently execute assigned experiments and may plan or lead smaller, well-defined studies or work items supporting phase-appropriate formulation and drug product process development., • Analyse and interpret experimental data, identify trends or atypical results, draw scientifically supported conclusions, and recommend next steps within defined project parameters; escalate complex issues as appropriate., • Draft study plans, development reports, technical memos, and other scientific documentation with review from more experienced colleagues or management as appropriate., • Collaborate with project management, quality assurance, analytical, R&D, non-clinical, manufacturing, and external partners to support development activities, technology transfer, and clinical material production., • Communicate study progress, timelines, results, risks, and recommendations clearly to the manager and project team to support alignment and timely decision-making., • Perform physicochemical and bioanalytical characterization using established analytical instrumentation and techniques and contribute to optimization of methods when needed., • Prepare samples, solvents, standards, buffers, and other solutions with accurate calculations, weighing, documentation, and adherence to laboratory safety and Good Documentation Practices., • Maintain laboratory notebooks, study documentation, inventory, and instrument maintenance schedules; contribute to laboratory organization and process improvements and may provide guidance to less-experienced colleagues on established procedures., • Perform other duties as assigned.Required Skills:, • Working to strong understanding of the biochemical and physical properties of therapeutic biologics, including proteins and other relevant modalities, and of commonly used protein quantification and characterization approaches., • Relevant experience with formulation, drug product, analytical, or related development activities for biologics; able to apply established scientific principles and procedures to assigned work., • Hands-on experience with commonly used characterization and analytical instruments in a biologics drug product laboratory, with sufficient understanding of assay principles to independently perform routine work and troubleshoot minor instrument or method issues., • Ability to analyze testing results, recognize trends and out-of-trend or atypical data, summarize findings, and make scientifically supported conclusions and recommendations within defined parameters., • Strong technical writing skills with the ability to draft clear SOPs, study plans, best practices, technical reports, memos, and similar documentation., • Ability to independently perform basic to moderately complex formulation and drug product studies and, with appropriate guidance, contribute to study design and optimization for biological drug candidates., • Understanding of aseptic processing fundamentals and sterile fill-finish concepts for parenteral biological drug products., • Working knowledge of GxP principles and compliance expectations for biological drug products is preferred., • Strong organizational, analytical, and technical problem-solving skills; exercises sound judgment within established procedures and project objectives., • Experience supporting pharmaceutical product development, process scale-up, technology transfer, or clinical manufacturing is preferred., • Ability to prioritize assignments, manage multiple studies or work items, and meet deadlines with a high degree of accuracy and efficiency., • Effective team player and collaborator who communicates clearly and timely with peers, managers, cross-functional partners, and external collaborators., • Demonstrated Good Documentation Practices (GDP) and disciplined laboratory record keeping within a pharmaceutical or similarly regulated environment., • Demonstrated growth in scientific knowledge, methods, and techniques, with willingness to learn new tools and apply feedback to increasingly complex assignments., • Solid understanding of laboratory safety requirements and experience working safely in bioanalytical or pharmaceutical development laboratories.#sczr2

Job Description Fate Therapeutics is seeking a Clinical Trial Manager or Senior Clinical Trial Manager to lead complex clinical studies from start-up through close-out, ensuring high-quality execution, strong site and vendor partnerships, and timely delivery of key milestones. This role is ideal for a highly organized and proactive clinical operations leader who is motivated to advance innovative therapies in oncology and/or autoimmune disease. The successful candidate will bring hands-on clinical operations experience, sound judgment, and the ability to lead cross-functional teams, solve problems proactively, and communicate clearly in a fast-paced environment. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA. Responsibilities • Independently lead complex or high-risk clinical trials from start-up through close-out, including study team leadership, timelines, enrollment strategy recommendations, risk mitigation, and completion planning., • Ensure study deliverables are completed on time, within budget, and in compliance with GCP/ICH requirements, company SOPs, and applicable quality standards., • Manage study budgets, forecasts, projections, invoice review and approval, and vendor spend in partnership with Finance and Clinical Operations., • Lead site identification, evaluation, qualification, initiation, monitoring, booster visits, and close-out; partner with investigators, site staff, and field personnel to support study conduct and timely data collection., • Develop and oversee enrollment strategies, monitoring plans, source document verification, data review, cleaning, freeze readiness, and data quality activities., • Manage clinical vendors, including RFI/RFP support, vendor evaluation, selection, oversight, issue resolution, and performance management., • Oversee Trial Master File implementation and maintenance to ensure ongoing inspection readiness., • Drive development, review, and approval of study documents and tools, including protocols, informed consent forms, budgets, monitoring reports, project plans, logs, templates, newsletters, and operational materials., • Provide concise study updates, reports, risks, and issues to senior management; escalate concerns promptly with recommended solutions., • Provide oversight, training, mentoring, delegation, and dotted-line management, as applicable, for CTMs, CTAs, CRAs, and assigned clinical trial staff., • Develop and deliver study training for investigators, site staff, and internal teams; support study supplies management and related operational processes., • Support internal process, vendor, and site quality audits and regulatory inspections, including preparation, participation, and follow-up., • Lead or participate in internal and external study meetings, Investigator Meetings, iDMC meetings, conferences, and events., • Develop SOPs, best practices, and process improvements to strengthen clinical trial execution.Qualifications, • B.S. degree with at least 6 years of clinical trial management experience in a biotech, pharmaceutical, and/or CRO environment., • Strong clinical operations expertise, including end-to-end study conduct from start-up through close-out, global trial execution, and CRO/vendor management., • Highly organized and self-directed, with the ability to manage multiple priorities, meet deadlines, and work with minimal supervision., • Oncology, autoimmune, or cell therapy experience highly preferred., • Working knowledge of FDA/ICH guidelines, Good Clinical Practice, clinical trial initiation and management practices, and pharmaceutical and clinical development processes., • Demonstrated leadership, decision-making, problem-solving, and cross-functional study team management skills., • Ability to engage, influence, and collaborate effectively across matrixed organizations and with external partners, including investigators, clinical sites, and vendors., • Excellent communication skills and professional demeanor; able to work effectively with medical personnel, clinical monitors, statisticians, data managers, medical writers, and internal cross-functional partners.Working Conditions & Physical Requirements, • Travel required, including periodic site visits and conferences to ensure the integrity of the study., • Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.Compensation, • The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location., • Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package., • The anticipated salary range for this role is $135,000 - $180,000. The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. Equal Employment Opportunity Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. Privacy Notice To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. ⚠️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud: - Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain. - At no stage in our hiring process will we require payment or ask you to make deposits in your bank account. - We will only ask for personal information when applying for a position via our Careers page or thereafter. - At no stage during our hiring process will we ask you to click a link to begin a one-way video interview. - We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at careers@fatetherapeutics.com to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description The Zifo Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. *This role will require 100% presence on-site at the client in San Diego, CA This role is not eligible for relocation assistance Requirements Required Skills: • Excellent customer service skills complemented by an ability to listen to and interpret client requests, • Ability to troubleshoot complex instrument and technology issues, • Strong oral and written communication skills, • Ability to identify, track and complete tasks for multiple projects, • Knowledge of laboratory safety practices as defined by the company and/or customer’s site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: • Requirements Management and onsite Validation/Compliance support, • IT Consulting, • Customer Liaison, • Onsite Lab IT Support Requirements Management • Understand problem statement/challenges, • Define scope, • Gather requirements., • Assist with Validation/Compliance activities (IOPQ) as required., • Analyze current state business processes and requirements., • Assist in building plans for process improvement IT Consulting • Analyze gaps/opportunities for improvement based on industry Best Practice, • Evaluate Industry trends to identify areas for optimization, • Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept, • Recommend process improvements that fit business needs Customer Liaison: • Meeting with internal/external service groups/leads, • Liaise between System/Lab owners and third parties to coordinate best times for services, • Provide weekly planning schedules for review at status meeting with customer leads, • Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: • Perform break/fix support for all Instrument connected systems, • Implement Windows based security policies as required, • Ensure adherence to client’s corporate policies through periodic reporting & compliance programs, • Acts as the technical support contact for field service engineers and external vendors, • Provide technical subject matter expertise for new system validation and change management, • Create and maintain a physical inventory of lab equipment, PC’s, software, and any other information pertinent to the environment if applicable, • Perform system preventative maintenances based on client’s schedule, if applicable Requirements • Bachelor’s/Master’s degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical, • 5+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems, • At least 3 years in software development and testing., • At least 2 years of experience in business requirement analysis and gathering., • Demonstrated domain area knowledge., • Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client’s confidence and trust., • Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry:, • Drug Discovery & Development Processes, • Clinical study planning & Data management, • Lab Workflows, • Chemical & Biologics material Management, • Sample Management, • Robotic Systems Integration & Qualification, • Operations KPI and Metrics tracking, • Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820, • Technical Skills:, • Operating System familiarity with at least 1 of the following: Unix, Windows, MVS, • Software Methodology familiarity with: Object Oriented Programming, Structured Programming, • Software Development Process familiarity with: Waterfall, Agile, • Change Control Management and Risk Management, • Office Tools proficiency required in : MS Word, Excel, PowerPoint, • Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies. We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Description Location: San Diego, CA This role will require full-time on-site presence at our client site in San Diego, CA. This role is NOT eligible for relocation assistance The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. Requirements Required Skills: • Excellent customer service skills complemented by an ability to listen to and interpret client requests, • Ability to troubleshoot complex instrument and technology issues, • Strong oral and written communication skills, • Ability to identify, track and complete tasks for multiple projects, • Knowledge of laboratory safety practices as defined by the company and/or customer’s site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: • Requirements Management and onsite Validation/Compliance support, • IT Consulting, • Customer Liaison, • Onsite Lab IT Support Requirements Management • Understand problem statement/challenges, • Define scope, • Gather requirements., • Assist with Validation/Compliance activities (IOPQ) as required., • Analyze current state business processes and requirements., • Assist in building plans for process improvement IT Consulting • Analyze gaps/opportunities for improvement based on industry Best Practice, • Evaluate Industry trends to identify areas for optimization, • Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept, • Recommend process improvements that fit business needs Customer Liaison: • Meeting with internal/external service groups/leads, • Liaise between System/Lab owners and third parties to coordinate best times for services, • Provide weekly planning schedules for review at status meeting with customer leads, • Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: • Perform break/fix support for all Instrument connected systems, • Implement Windows based security policies as required, • Ensure adherence to client’s corporate policies through periodic reporting & compliance programs, • Acts as the technical support contact for field service engineers and external vendors, • Provide technical subject matter expertise for new system validation and change management, • Create and maintain a physical inventory of lab equipment, PC’s, software, and any other information pertinent to the environment if applicable, • Perform system preventative maintenances based on client’s schedule, if applicable Requirements • Bachelor’s/Master’s degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical, • 3+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems, • At least 1 year in software development and testing., • At least 1 year of experience in business requirement analysis and gathering., • Demonstrated domain area knowledge., • Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client’s confidence and trust., • Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry:, • Drug Discovery & Development Processes, • Clinical study planning & Data management, • Lab Workflows, • Chemical & Biologics material Management, • Sample Management, • Robotic Systems Integration & Qualification, • Operations KPI and Metrics tracking, • Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820, • Technical Skills:, • Operating System familiarity with at least 1 of the following: Unix, Windows, MVS, • Software Methodology familiarity with: Object Oriented Programming, Structured Programming, • Software Development Process familiarity with: Waterfall, Agile, • Change Control Management and Risk Management, • Office Tools proficiency required in : MS Word, Excel, PowerPoint, • Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job DescriptionDescription: The Device / Combination Product Manager serves as the internal technical leader and subject-matter expert for medical device and drug-device combination product development across Viking Therapeutics’ pipeline. This role partners closely with internal Chemistry, Manufacturing and Controls (CMC), Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain teams, as well as with external device suppliers, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs), to plan and execute phase-appropriate device and combination product activities from early development through late-stage clinical and pre-commercial readiness. The Device / Combination Product Director will establish and oversee design controls, risk management, human factors, and design verification and validation for the device constituent parts of combination products (such as prefilled syringes, autoinjectors, and pen injectors), and will ensure compliance with applicable combination product and device regulations. The role will contribute device and combination product content to CMC documentation and regulatory submissions across Viking’s portfolio, including the company’s lead GLP-1/GIP dual agonist program (VK2735) and additional metabolic and endocrine disorder pipeline assets. The level of the role will be commensurate with the candidate’s experience and qualifications. Essential Duties and Responsibilities The main responsibilities of this role include: • Serve as the internal subject-matter expert and technical lead for medical device and combination product development across Viking’s portfolio, including the device constituent parts of drug-device combination products such as prefilled syringes, autoinjectors, and pen injectors., • Establish and maintain design control processes (per 21 CFR 820.30 and ISO 13485) and the Design History File (DHF), including user needs, design inputs and outputs, design reviews, and design verification and validation., • Lead device and combination product risk management activities in accordance with ISO 14971, including hazard analysis, design and use FMEAs, and benefit-risk assessment throughout the product lifecycle., • Direct human factors and usability engineering programs (per IEC 62366-1 and applicable FDA human factors guidance), including formative and summative studies, use-related risk analysis, and instructions for use., • Oversee device and combination product activities at external suppliers, device CMOs, and CDMOs, including design transfer, component qualification, biocompatibility (ISO 10993), and manufacturing and assembly controls., • Author and review device and combination product sections of regulatory submissions (INDs, CTAs, NDAs/BLAs) consistent with 21 CFR Part 4 combination product cGMP requirements, and support responses to health authority questions in collaboration with Regulatory Affairs., • Define device specifications, essential performance requirements, acceptance criteria, and control strategies; support container-closure, extractables and leachables, and device performance testing in partnership with Drug Product and Analytical Development., • Partner cross-functionally with CMC, Drug Product, Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure integrated, phase-appropriate, on-time combination product deliverables., • Provide device and combination product updates, risk assessments, and timelines at integrated project team meetings and to executive stakeholders, and help build internal device capability, processes, and governance., • Other duties as assigned. Requirements: Education and Experience • B.S. in Biomedical Engineering, Mechanical Engineering, a related engineering field, or a relevant scientific discipline, with 10+ years of medical device and/or combination product development experience in the pharmaceutical, biotech, or medical device industry; or M.S. with 8+ years; or an equivalent combination of education and experience., • Title and level (Director vs. Senior Director) will be commensurate with the candidate’s experience and qualifications. Knowledge and Skills • Demonstrated hands-on experience developing drug-device combination products (e.g., prefilled syringes, autoinjectors, pen injectors) from concept through commercialization, including design and integration of the device constituent part., • Working knowledge of combination product and device regulations and standards, including 21 CFR Part 4, 21 CFR 820 (Quality System Regulation), ISO 13485, ISO 14971, IEC 62366-1, and ISO 10993., • Experience establishing and managing design controls, Design History Files, design verification and validation, and human factors / usability engineering programs., • Track record of managing external device suppliers, CMOs, and CDMOs, including design transfer, component qualification, and delivery on time and within budget., • Experience authoring device and combination product sections of regulatory submissions and supporting health authority interactions in collaboration with Regulatory Affairs., • Experience with parenteral / injectable delivery systems and, ideally, peptide or GLP-1/GIP combination products and associated cold-chain considerations, is a plus., • Strong written and verbal communication skills; ability to translate technical device matters into clear documentation and regulatory content, and to influence cross-functional and executive stakeholders., • Entrepreneurial mindset with the ability to thrive in a fast-paced, lean biotech environment; strong organizational skills, attention to detail, and the ability to build internal capability while managing multiple priorities and external partners simultaneously. VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Salary Description $110,000.00 - $135,000.00 annual salary

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We're seeking an Information Security Analyst with a foundational background in IT support, system administration, or security operations and an interest in growing their career in information security. This role will support the implementation, monitoring, and maintenance of security controls across endpoint, identity, and Microsoft 365 environments. The ideal candidate is detail-oriented, eager to learn, and comfortable working with established processes, documentation, and security tools under the guidance of senior team members. Responsibilities • Assist with monitoring security alerts and escalate issues to senior team members as needed., • Support endpoint security and compliance efforts within Microsoft Intune and related Microsoft security tools., • Help maintain device compliance policies, configuration profiles, and security settings following established standards., • Participate in testing and validation of security changes, policy updates, and endpoint configurations., • Assist with user and device access reviews, MFA support, and identity-related security tasks., • Help document procedures, standards, and troubleshooting steps in runbooks or internal knowledge bases., • Work with IT teams to investigate security issues, configuration inconsistencies, and endpoint compliance gaps., • Assist with routine reporting, tracking remediation items, and following up on assigned security tasks., • Contribute to security awareness and continuous improvement efforts as assigned., • Use PowerShell and/or Intune remediation scripts to automate repetitive tasks, reporting, and configuration drift checks. Requirements • Bachelor's degree in Information Security, Information Technology, Computer Science, or a related field, or equivalent practical experience, • 1 + years of experience in Information Security, System Administration, Help Desk or similar roles, • Exposure to MDM/MAM policies for Windows/MacOS/iOS/Android, • Demonstrated hands-on experience administering Microsoft Defender Portal, in the following areas: Sentinel, Secure Score, Cloud Apps, • Strong analytical and problem-solving skills with the ability to investigate alerts, interpret audit logs, and distinguish signal from noise, • Effective written and verbal communication skills, with the ability to explain technical concepts to non-technical stakeholders, • Ability to follow established procedures, manage assigned tasks, and escalate when appropriate. Preferred • Microsoft certifications relevant to security and compliance, • Prior experience in the pharmaceutical, biotech, or life sciences sector, • Exposure to SIEM tools, endpoint detection and response (EDR) platforms, or identity and access management systems, • Comfortable working across functional teams including Legal, Compliance, HR, and IT, and possesses the judgment to handle sensitive data and insider risk information with appropriate discretion., • Exposure to Intune device configurations and MDM Policies Wisconsin pay range $65,000—$80,000 USD California pay range $75,000—$90,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job Description About BlossomHill Therapeutics: BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors. For more information visit BlossomHill Therapeutics. Associate Director/Director, Accounting The Associate Director, Accounting or Director, Accounting is a key member of BlossomHill’s accounting and finance organization and will play a hands-on role in the Company’s public-company accounting, financial reporting and close processes. The position is responsible for leading and supporting core accounting operations, including the monthly and quarterly close, general ledger, payroll oversight, equity administration and stock-based compensation, R&D and clinical accruals, and internal controls. The successful candidate will combine strong technical accounting and operational skills with a collaborative, improvement-oriented approach and a demonstrated ability to mentor and develop team members. Key Responsibilities: • Lead key aspects of the monthly, quarterly and annual close processes, including review of journal entries, account reconciliations, financial statement fluctuations and supporting schedules, while ensuring timely and accurate completion of close activities., • Support equity administration activities and the accounting for stock-based compensation, including equity award activity; partner with third-party equity administrators to maintain accurate equity records and reporting., • Support payroll accounting and related close activities, including review of payroll reconciliations, accruals, employee-related liabilities and coordination with HR and payroll service providers., • Prepare and/or review R&D and clinical accruals and related accounting, partnering with Clinical Operations and other internal stakeholders to evaluate vendor activity, contracts, purchase orders, milestones and other available information to support complete and accurate expense recognition in the appropriate period., • Support the development and ongoing enhancement of R&D accrual methodologies, reconciliations and related controls; coordinate with external vendors and internal teams to obtain timely information, investigate variances and improve the accuracy and efficiency of the accrual process., • Support the preparation, review and tie-out of quarterly and annual SEC filings, including footnotes and supporting disclosure schedules, • Support the design, implementation and ongoing enhancement of internal controls over financial reporting, including SOX readiness and compliance initiatives, process documentation, control execution, testing support and remediation activities., • Lead and support internal and external audit activities, including preparation and review of audit support, coordination of requests and timely resolution of questions and recommendations., • Mentor, coach and develop accounting team members; establish clear ownership and expectations, provide regular feedback, and promote cross-training to strengthen team capabilities, coverage and succession readiness., • Identify and lead opportunities to automate accounting activities, streamline close and reporting procedures, improve system utilization and eliminate manual or duplicative processes while maintaining appropriate controls., • Develop and maintain scalable accounting procedures, reconciliations, checklists and reporting schedules appropriate for a growing public company. Qualifications: • Bachelor’s degree in Accounting, Finance or a related field., • 8+ years of progressive accounting or finance experience, with commensurate experience with the Associate Director or Director level., • Strong knowledge of U.S. GAAP and experience with relevant accounting and financial reporting matters., • Experience supporting a public-company close and external reporting environment, including quarterly and annual reporting processes., • Demonstrated experience leading workstreams, reviewing the work of others and developing accounting team members., • Strong analytical, organizational and project-management skills, with the ability to manage multiple priorities and deadlines in a fast-paced environment., • Strong written and verbal communication skills and the ability to work effectively with cross-functional stakeholders and external service providers., • Must be eligible to work in the United States without the need for work visa or residency sponsorship. Preferred Qualifications: • CPA desired., • Public accounting experience., • Experience in a publicly traded biotechnology, pharmaceutical or life sciences company, or another high-growth public-company environment., • Experience preparing or reviewing R&D and clinical accruals and partnering with Clinical Operations, CROs or other external research and development vendors., • Hands-on experience with SEC reporting, including preparation or detailed tie-out of Forms 10-Q and 10-K and related financial statement disclosures., • Experience with equity administration platforms and accounting for stock-based compensation., • Experience with SOX 404 readiness or ongoing compliance., • Experience overseeing payroll accounting and partnering with HR on payroll and equity-related matters., • Experience with ERP and financial reporting systems process improvement, automation and systems optimization., • Proven ability to build collaborative relationships, mentor and develop team members, and create effective cross-training. Equal Employment Opportunity: The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Recruiters and Agencies: BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHill employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired. E-Verify: BlossomHill Therapeutics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) to resolve the issue. Recruitment Fraud Notice: BlossomHill Therapeutics will never send applicants a check, ask them to purchase equipment or gift cards, or request payment of any kind. Legitimate recruiting communications come only from an @bhtherapeutics.com email address, and all open positions can be verified through our official website. Sensitive onboarding information is collected only through BHT’s authorized onboarding process after an employment offer has been independently verified. If you receive suspicious recruiting communications claiming to represent BlossomHill Therapeutics, please contact Human Resources at our company.

Job DescriptionDescription: The Manager, Injectable Products serves as a technical leader and Subject Matter Expert (SME) for sterile injectable drug products across late-stage development, Process Performance Qualification (PPQ), commercial launch, regulatory approval, and lifecycle management activities. This role provides strategic and hands-on technical leadership for biologic and small molecule injectable products, including liquid, lyophilized, and combination presentations. The individual will support technology transfer, process validation, commercial manufacturing, regulatory submissions, inspection readiness, and continuous process improvement initiatives. The position partners closely with Pharmaceutical Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Analytical Development, and external manufacturing partners (CMOs/CDMOs) to ensure robust, compliant, and reliable manufacturing processes throughout the product lifecycle. Essential Duties and Responsibilities The main responsibilities of this role include: Injectable Product Technical Leadership • Serve as the technical SME for sterile injectable products from Phase 3 clinical development through commercial operations., • Provide technical leadership for drug product manufacturing processes, including formulation, filling, lyophilization, inspection, packaging, and distribution., • Support process characterization, control strategy development, validation, and lifecycle management activities., • Ensure compliance with FDA, EMA, ICH, and global regulatory requirements for sterile injectable products., • Support preparation and defense of CMC content for regulatory submissions, inspections, and agency interactions. Manufacturing & Technical Operations Support • Provide technical oversight for commercial manufacturing operations involving sterile injectable products., • Support technology transfer activities between development organizations, CMOs, CDMOs, and commercial manufacturing sites., • Lead technical investigations associated with manufacturing deviations, process excursions, product quality events, and yield improvements., • Support PPQ execution, Continued Process Verification (CPV), Annual Product Reviews, and ongoing process monitoring initiatives., • Identify and implement process improvements that enhance product quality, manufacturing robustness, compliance, and supply reliability., • Serve as a technical representative during Health Authority inspections and Pre-Approval Inspections (PAI). Process Validation & Lifecycle Management • Lead process validation strategies and execution for commercial injectable products., • Review and approve validation protocols, reports, risk assessments, and change controls., • Support equipment qualification, cleaning validation, aseptic process simulations, and container closure validation activities., • Drive lifecycle management activities, including post-approval changes, process optimization, and manufacturing scale-up initiatives., • Ensure product and process knowledge is effectively transferred and maintained across manufacturing sites. Sterile Manufacturing Expertise • Provide technical support for aseptic processing, sterile filtration, filling operations, lyophilization, and visual inspection processes., • Evaluate manufacturing performance trends and recommend improvements to process capability and operational efficiency., • Support contamination control strategies and aseptic manufacturing best practices., • Collaborate with site operations to resolve technical challenges and support uninterrupted product supply. Investigations, Quality & Compliance • Lead complex investigations related to product quality, manufacturing deviations, out-of-specification results, and process performance issues., • Facilitate root cause analysis and development of effective CAPAs., • Ensure compliance with GMP requirements and internal quality systems., • Participate in audits, inspection readiness activities, and regulatory responses., • Apply Quality Risk Management principles to support decision-making and process improvements. CMC & Regulatory Support • Provide technical support for regulatory submissions, supplements, annual reports, and responses to health authority questions., • Collaborate with Regulatory Affairs and Development teams to support product approvals and post-approval changes., • Ensure alignment between manufacturing processes, control strategies, and regulatory commitments., • Support inspection preparation and regulatory agency interactions. Supplier & External Partner Management • Provide technical oversight of CMOs, CDMOs, and critical raw material suppliers., • Support supplier qualification, technical assessments, investigations, and change management activities., • Collaborate with external partners to resolve manufacturing and quality challenges., • Evaluate manufacturing capabilities and readiness to support commercial product demand. Cross-Functional Collaboration • Partner with Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Engineering functions., • Support commercialization activities and launch readiness initiatives., • Drive alignment between internal stakeholders and external manufacturing organizations., • Contribute technical expertise to strategic product and portfolio decisions. Project Leadership • Lead technical workstreams supporting product commercialization, process validation, technology transfer, and lifecycle management., • Mentor junior engineers and scientists within the organization., • Manage multiple projects and priorities while ensuring timelines, quality standards, and business objectives are achieved., • Support strategic initiatives within the Injectables & Devices organization., • Other duties as assigned.Requirements: Education and Experience • BS or MS in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemistry, Biology, or related scientific discipline., • 8+ years of experience in pharmaceutical or biotechnology manufacturing and technical operations., • Direct experience supporting sterile injectable products from late-stage development through commercial launch., • Experience supporting PPQ, technology transfer, process validation, and commercial manufacturing operations., • Strong understanding of aseptic processing, sterile manufacturing, and injectable drug product lifecycle management., • Experience leading technical investigations, CAPAs, change controls, and risk assessments., • Knowledge of FDA, EMA, ICH, GMP, and global regulatory requirements., • Demonstrated experience supporting regulatory inspections and audit readiness activities., • Strong project management, technical writing, and cross-functional leadership skills., • Excellent communication and stakeholder management capabilities. Knowledge and Skills • Sterile Injectable Product Expertise, • Technical Operations Leadership, • Process Validation & PPQ Execution, • Aseptic Manufacturing Knowledge, • Commercialization & Lifecycle Management, • Regulatory Compliance & Inspection Readiness, • Quality Risk Management, • Cross-Functional Leadership, • External Partner Management, • Strategic Problem Solving, • Continuous Improvement & Operational Excellence Preferred: • Advanced degree (MS, PharmD, or PhD) in Engineering, Pharmaceutical Sciences, or related scientific field., • Experience with biologics, monoclonal antibodies, peptides, gene therapies, or other sterile injectable products., • Experience with lyophilized drug products and aseptic filling operations., • Experience supporting global regulatory submissions and product approvals., • Experience managing CMOs/CDMOs and global manufacturing networks., • PMP, Lean Six Sigma, or related certification. VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Salary Description $140,000.00 - $155,000.00 annual salary

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW Syner-G is seeking a Facilities Technician III with 5–10 years of experience to support the operation, maintenance, and repair of GMP and non-GMP facility systems, utilities, and equipment. This role is responsible for performing advanced maintenance activities, troubleshooting complex issues across multiple building systems, and supporting reliability and compliance requirements in laboratory, manufacturing, and utility environments. The Facilities Technician III works with minimal supervision, handles complex technical challenges, and may guide junior staff as needed to ensure safe and efficient facility operations. WORK LOCATION Travel to client sites may be required depending on project demands and client expectations. KEY RESPONSIBILITIES (This list is not exhaustive and may be modified as needed.) • Perform advanced preventive and corrective maintenance activities on mechanical, electrical, HVAC, utility, safety, and building systems across GMP and non-GMP areas., • Receive, prioritize, and execute work order requests from employees, tenants, and internal customers, ensuring timely and efficient response to facility needs., • Troubleshoot and resolve complex technical issues involving HVAC systems, electrical distribution, plumbing, mechanical utilities, generators, environmental controls, and related infrastructure., • Inspect facility systems and equipment to identify maintenance needs, operational risks, or abnormal conditions and escalate issues when required., • Make repairs directly when possible and coordinate specialized contractors or vendors when complex repairs are needed., • Work independently with minimal supervision while handling complex maintenance tasks requiring strong technical judgment., • Maintain accurate maintenance records, including work orders, equipment logs, inventory tracking, and compliance-related documentation., • Support calibration activities and equipment reliability programs as needed., • Ensure compliance with all safety regulations, facility procedures, and applicable GMP or regulatory standards., • Provide technical support, guidance, or mentoring to junior technicians as required., • Collaborate with cross-functional partners including Laboratory Operations, Engineering, Quality, Safety, and other stakeholders to support continuous facility operations., • Identify and recommend improvements, upgrades, or cost-effective solutions that enhance system reliability, energy efficiency, or facility performance., • Perform additional duties as assigned. QUALIFICATIONS AND REQUIREMENTS Education • High school diploma required; technical trade school certifications or equivalent field experience considered., • Registered apprenticeship, trade license (electrical, plumbing, HVAC, pipefitting, wastewater, steam engineering, marine engineering), or equivalent technical training strongly preferred. Experience • 5–10 years of relevant experience in facility maintenance, utilities support, or mechanical/electrical building systems., • Experience in regulated environments such as cGMP biotech, pharmaceutical, or laboratory operations preferred. Knowledge, Skills, and Abilities • Strong technical skills in HVAC, electrical, plumbing, mechanical systems, and building utilities., • Ability to troubleshoot and resolve complex facilities issues independently., • Proficient in reading schematics, blueprints, technical manuals, loop diagrams, and Pdummyamp;IDs., • Familiarity with Building Management Systems and Computerized Maintenance Management Systems (CMMS)., • Effective communication and customer service skills., • Ability to perform physical labor and work across multiple facility environments. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous paid time away program and company-paid holidays. The expected salary range for this position is $43 to $45 hourly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.