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Job DescriptionDescription: REPORTS TO Chief Operating Officer JOB DESCRIPTION/SUMMARY The Senior Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. This position is responsible for primary authorship and supporting CMC regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements maintaining the electronic trial master files, reviewing, and overseeing the production of clinical and regulatory documents in support of product development applications. ESSENTIAL DUTIES AND RESPONSIBILITIES The main Regulatory Affairs responsibilities of this role include but are not limited to the following: • Serves as the regulatory lead on CMC development teams, providing guidance and oversight., • Manages administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time., • Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings., • Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed., • Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs., • Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams., • Collaborates with and supervises contributions from contractors and vendors., • Develops and manages project timelines for regulatory submissions., • Manages and maintains the electronic trial master files for regulatory, clinical, and non-clinical departments., • Bachelor's degree in scientific discipline with at least 5 years of experience in CMC Regulatory Affairs., • Proven success in preparing and submitting CMC sections of INDs, CTAs, NDAs, and MAAs, • Deep understanding of global regulatory frameworks and evolving guidelines, • Ability to lead in a fast-paced, collaborative environment with shifting priorities, • Strategic mindset with a hands-on approach to problem-solving and execution, • Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD., • Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle., • Working knowledge of FDA and ICH regulatory guidance and regulations., • High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom, • High attention to detail and excellent proofreading and editing skills, • Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion, • Ability to multi-task, professional demeanor, strong attention to detail, • Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude, • Must be dependable; someone willing to go the extra-mile to get things done 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.

Job DescriptionCompany Description Eurofins Scientific is a network of independent companies providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With more than 20 U.S. locations, Eurofins Built Environment Testing offers Industrial Hygiene (IH) and Indoor Air Quality (IAQ) services to protect health in built environments. Clients include consultants, industry, real estate, healthcare, government, and homeowners. Services cover a wide range of tests, including asbestos (PLM/TEM), mold, bacteria, VOCs, allergens, Legionella, radon, lead, silica, and more. Job Description Eurofins Built Environment Testing is searching for an Asbestos Analyst in San Diego, CA The Analyst primarily performs analysis of bulk samples using PLM for asbestos. Analyst prepares and analyzes environmental samples according to scientific methodology in compliance with company Quality Assurance programs and SOP’s, and must be knowledgeable of both job-specific routine and complex analyses. The analyst validates and reviews data for accuracy, and enters laboratory data into the LIMS that ultimately generates required reports to clients. Schedules sample workload according to due dates and sample hold times, and must be knowledgeable of the job-specific laboratory testing equipment, requiring the exercise of discretion and judgment in its operation. Asbestos Analyst responsibilities include, but are not limited to, the following: * Prepare and analyze aerobiological and environmental samples for asbestos. * Accurately enters and reports analytical data using the LIMS * Performs independent data reviews for other analysts’ work * Performs analysis of reference materials, proficiency samples and other quality control samples as needed * Maintains client service and provides technical support as needed * Assists the QA manager in development, implementation and data collection of QA processes for the different analytical tests * Performs confirmation of lab results as needed by client services personnel * Performs and completes all analytical testing and Quality Assurance related tasks as needed * Assists in pursuing, receiving and maintaining necessary laboratory accreditations * Maintains and updates all necessary Training and QA documents onsite as necessary * Coordinates and manages projects according to their rush status and due time for timely delivery * Assists co-workers on analytical questions, as necessary * Participates in Lean initiatives as needed * Follows company policies and procedures and ensures that coworkers are doing the same * Manages and maintains the inventory of re-sale supply items and laboratory consumables and takes necessary steps to re-order supplies as needed * Manages and disposes analyzed samples as needed * Provides training support for relevant analytical services (i.e. mycology, bacteriology, asbestos, ect) as needed * Recommends and coordinates sample transfer as necessary * Performs root cause analysis and implements corrective actions for errors and issues as necessary * Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory, as needed * Supports other departments within the lab (mycology, asbestos, bacteriology, and other) when appropriate and as needed * Other responsibilities as deemed necessary by the Supervisor/Manager Qualifications Basic Minimum Qualifications: * 0 -1+ years of experience performing asbestos microscopy preferred * Bachelor’s degree in microbiology, biology, geology or a closely related science * Authorization to work in the United States indefinitely without restriction or sponsorship * Professional working proficiency in English is a requirement, including the ability to read, write and speak in English The ideal candidate would also possess: * 8 units of Microbiology courses preferred * General regulatory requirements knowledge * Knowledge of computers, spreadsheets, and databases * Strong computer, scientific, and organizational skills Additional Information Compensation Range: $22-$24 per hour depending on experience and qualifications. Higher compensation may be considered for candidates with Asbestos Testing PLM experience. Position is full-time, Monday - Friday, 10:30am - 7:00pm with weekends and overtime as needed. Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionCompany Description Eurofins Scientific is a network of independent companies providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With more than 20 U.S. locations, Eurofins Built Environment Testing offers Industrial Hygiene (IH) and Indoor Air Quality (IAQ) services to protect health in built environments. Clients include consultants, industry, real estate, healthcare, government, and homeowners. Services cover a wide range of tests, including asbestos (PLM/TEM), mold, bacteria, VOCs, allergens, Legionella, radon, lead, silica, and more. Job Description The Lab Manager will manage a team of Mold and Asbestos Analysts and other Laboratory staff, provide leadership and be responsible for ensuring compliance of laboratory operations. Will help maintain/adjust workflow to meet TAT, make recommendations, as needed, to improve laboratory functionality, and supervising staff. Will be responsible for ensuring compliance and integration of facility operation with quality assurance, ethics, safety and other corporate and regulatory policies and procedures. Essential Duties and Responsibilities 1. Provide leadership and manage/assist other staff members in the operational team., 2. Assists with the coordination and timely completion of all analytical and operational training for the local lab staff., 3. Prepare and analyze aerobiological, environmental, and water samples for fungal, asbestos and bacteria analysis., 4. Serve as an operational point of contact for clients regarding all services performed in the lab., 5. Coordinates with the local salesperson to assist with client concerns., 6. Determines the local client needs and leads the effort in adding new testing services as needed to meet the local client needs., 7. Coordinates the work of the local lab and assists in setting work priorities to minimize costs, scheduling conflicts or delays., 8. Reviews and modifies group schedules based on current and projected workloads and staffing. Prioritizes the activities of the groups to ensure key goals are achieved and customer service needs are addressed. Manage personnel schedules for Monday-Friday and Tuesday-Saturday staff., 9. Builds and maintains positive customer relationships through direct interaction with customers, project managers, and sales personnel., 10. Fosters morale and teamwork. Fulfills supervisory responsibilities with direct reports to achieve strong staff performance. Mentors key employees., 11. Demonstrates and promotes the company vision. Communicates facility-specific goals and objectives to employees. Communicates and implements company initiatives designed to foster teamwork and communication., 12. Establishes and maintains an active and positive safety culture and ensures that the Employee Health and Safety procedures are implemented and followed to maintain facility operations that are compliant with appropriate policies and regulations., 13. Reviews SOPs used in the facility and ensures their implementation so that the facility is operated in a compliant manner which allows it to produce defensible data., 14. Supports the Human Resources function to ensure that all policies and programs are applied consistently throughout the laboratory. Secondary Duties 1. Remains current on new technological developments and provides scientific leadership in establishing new analytical services as needed, works with Technical Director., 2. Assists the QA manager in development, implementation, and data collection of QA processes for the different analytical tests., 3. Assists in pursuing, receiving, and maintaining necessary laboratory accreditations., 4. Recommends and coordinates sample transfer as necessary., 5. Assists co-workers with analytical questions as necessary., 6. Ordering and inventory control for lab supplies and equipment. • Strong Professional background in working with Mold and Asbestos Samples, • Previous Supervisory/Management experience required, preferably 2 yrs., • BS degree in Microbiology, Biology, or equivalent degree, • Minimum 3 years of previous hands on laboratory experience Additional Information Compensation Range: candidates who qualify with minimum requirements start at $75,000 annually. Higher compensation will be considered for more qualified experienced candidates. Position is full-time, exempt status. Experienced and qualified candidates are encouraged to apply. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6.95 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionVTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems. RESPONSIBILITIES: • Develops test plans, test cases, and test scripts on multiple projects simultaneously., • Scheduling and execution of qualification activities, • Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications., • Software Design Specification drafting and review., • Create, track, and complete regulated documentation for SW V&V process such as change orders, test plans, reports, and relevant attachments., • Documentation generation and updates (SOPs, PFMEA, Forms, etc.), • Meeting attendance and project coordination., • Basic SQL Knowledge for (SELECTS, JOINS, and execution queries)., • Identify defects and track them from discovery to resolution., • Conduct manual and automated testing of software., • Work with developers to perform root-cause analysis and preliminary problem diagnosis., • Provide all services in accordance with FDA cGxP guidelines and regulations.QUALIFICATIONS:, • Bachelor's degree or higher in Engineering, Life Sciences, or related discipline., • 7+ years of relevant FDA-regulated industry experience in Software Validation., • Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485, ISA 95, and GAMP 5., • Familiarity with Test Scripts, web reports, and databases., • 5+ years of proven experience with web reports, SQL queries, and Computerized Systems Validation., • Must have experience working in an FDA-regulated environment., • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, etc., • Exceptional technical writing, review, and analytical skills., • Experience with document control systems (Oracle Agile, Valgenesis, JAMA, etc), • Experience with issue tracking systems (Jira, Bugzilla) VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. Powered by JazzHR D8TDE40N1y

Job Description Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM&M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We’re looking to add an Associate Medical Editor to our Editorial Services team. The Associate Medical Editor role is entry-level and is ideal for individuals with minimal experience in editorial tasks or the healthcare/pharmaceutical industry who are eager to develop their expertise in medical editing. This role will work under supervision to gain proficiency in proofreading, copyediting, and applying the AMA Manual of Style (11th Edition) while becoming familiar with our agency’s tools, systems, and workflows. What You’ll Do • Proofread and copyedit a variety of scientific and medical materials, including manuscripts, slide decks, abstracts, and educational content for healthcare professionals and patients, • Ensure grammatical accuracy, consistency, and adherence to style guides (including AMA Manual of Style), • Verify that content aligns with scientific data, regulatory requirements, and client objectives, • Collaborate with medical writers, designers, project managers, and account managers to enhance the clarity and quality of deliverables, • Assist in maintaining consistency and compliance with ethical and industry standards, • Manage multiple projects under tight deadlines while ensuring high editorial standards What You’ll Have • Internship to 1 year of experience in an editorial capacity, • Bachelor's degree in English, Journalism, Communications, Life Sciences, or a related field, • Proficiency in Microsoft Office Suite; familiarity with editing tools and content management systems is a plus, • Strong attention to detail and ability to spot grammatical, stylistic, and factual inconsistencies, • Basic familiarity with medical terminology and scientific content is preferred, • Ability to learn quickly and work under supervision to develop expertise in medical editing, • Excellent time management and organizational skills to handle multiple projects What We Offer • Immediate eligibility for all benefits, including medical, dental, vision, group term life, short-term and long-term disability, • Benefits 100% company paid, • 401k plan employer matching contributions, • Eligibility for company sponsored incentive plans, • Generous PTO, including a week off in December for the holidays, • Paid volunteer time off, • Tuition reimbursement, • On-site gym and other employee wellness initiatives, • Employee Assistance Program, • Comp pay or comp time for onsite weekend work, • Availability of cell-phone stipends, based on business need, • Leadership development training program and other career development programs, • Remote and hybrid work schedule options, • Salary range: $50,000 – $60,000 annually. Note: Actual salary will depend on background and experience. M/F/D/V Please note, we will only respond to candidates we deem qualified

Job DescriptionDescription: We are seeking a highly motivated Senior Director / Head of Statistical Programming to establish and lead the programming function in a dynamic biotech environment. This role combines strategic leadership with hands-on technical contribution, supporting early- to late-phase oncology and other therapeutic programs. The successful candidate will oversee programming deliverables for clinical trials and regulatory submissions, manage CROs, and build internal capabilities to enable data-driven decision-making and accelerate drug development. Key Responsibilities Leadership & Strategy • Define and lead the statistical programming vision, strategy, and operating model in a growing biotech setting., • Serve as the functional lead for programming across all studies and development programs., • Provide expert input into protocol design, SAP development, and regulatory strategy. Execution & Delivery • Oversee and contribute to the creation of high-quality analysis datasets (ADaM), TFLs, and SDTM conversions to support clinical study reporting and regulatory submissions., • Act as programming lead for NDA/BLA/MAA deliverables, ensuring compliance with CDISC, ICH, and regulatory standards., • Implement efficient processes, templates, and standards to maximize quality and productivity in a resource-constrained environment., • Proactively troubleshoot and provide technical solutions for complex programming challenges. Collaboration & Oversight • Partner closely with Biostatistics, Data Management, Clinical, and Regulatory teams to ensure alignment and timely delivery., • Manage and oversee CROs/vendors, ensuring deliverables meet quality, cost, and timeline expectations., • Represent statistical programming in cross-functional governance meetings, study teams, and regulatory interactions. Team Building & Mentorship • Recruit, mentor, and develop a small but high-impact programming team., • Foster a culture of collaboration, accountability, and continuous learning., • Provide training, technical guidance, and career development support to staff. Why Join Us • Opportunity to shape and build the statistical programming function in a growing biotech., • High-impact role with direct influence on advancing innovative therapies to patients., • Collaborative, entrepreneurial culture with strong scientific focus., • Competitive compensation, equity participation, and comprehensive benefits. Requirements: • MS/PhD in Statistics, Biostatistics, Computer Science, Mathematics, or related field., • 10+ years of statistical programming experience in the pharmaceutical/biotech industry, with proven experience leading programming support for regulatory submissions., • Strong hands-on programming expertise in SAS; proficiency in R and/or Python highly desirable., • Excellent knowledge of CDISC (SDTM, ADaM), ICH, and regulatory guidance., • Demonstrated success managing CROs and delivering results in a fast-paced, resource-lean biotech environment., • Strong leadership, communication, and problem-solving skills, with ability to influence and collaborate across functions., • Passion for building teams and infrastructure from the ground up. Salary Details $250k - $300k yearly

Job DescriptionSalary: $110,000.00 - $130,000.00 - based on experience About Arthrosi Therapeutics Arthrosi Therapeutics is a clinical-stage biotech company committed to transforming the treatment paradigm for gout and related inflammatory diseases. Our lead candidate, AR882, is a best-in-class oral URAT1 inhibitor currently in Phase 3 clinical development. We are seeking to build a strong quality team that will play a pivotal role in our journey to regulatory approval and beyond. Position Summary The Quality System Manager, under the supervision of Quality Leadership, is responsible for executing and supporting day-to-day activities of GxP quality systems, with particular emphasis on document control, change control, and deviation management. This role ensures that quality processes are implemented in compliance with applicable regulatory requirements (FDA, EMA, ICH, ISO) and internal quality standards to maintain inspection readiness and support product development through commercialization Key Responsibilities Document Control • Administer the electronic Document Management System (eDMS) ensuring documents are created, reviewed, approved, distributed, and archived in compliance with regulatory and company standards., • Coordinate controlled document lifecycle: drafting, formatting, issuance, revision, retirement, and archival., • Maintain document templates, numbering systems, and access permissions., • Facilitate change control process by logging, tracking, and monitoring changes to GxP systems, procedures, and controlled documents., • Assist in risk assessment and impact analysis of proposed changes., • Coordinate cross-functional review and approval of change requests, ensuring timely closure., • Log and track deviations, errors, or nonconformances in the Quality Management System (QMS)., • Coordinate investigation activities, ensuring root cause analysis and appropriate corrective and preventive actions (CAPAs) are documented., • Monitor deviation and CAPA timelines to ensure compliance with internal metrics and regulatory expectations., • Administer the required training related to SOPs, policies, and GxP compliance., • Maintain accurate and complete quality records to ensure inspection readiness at all times., • Support preparation for internal audits, external audits, and regulatory inspections., • Generate routine metrics on document control, change control, deviations, and CAPA performance., • Proactively identify areas for process improvement within quality systems., • Support initiatives to streamline workflows, enhance compliance, and increase efficiency. Qualifications Education • 4-8 years of experience in a GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry)., • Experience with electronic Quality Management Systems (eQMS), Document Management Systems, or, • Understanding of FDA, EMA, and ICH GxP regulations and guidelines., • Strong organizational and time-management skills with ability to manage multiple priorities., • Excellent written and verbal communication skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook)., • Attention to detail and commitment to data integrity Preferred Attributes • Prior experience working in a company advancing a product from late-stage development to commercial launch., • Hands-on experience implementing or scaling electronic QMS tools and inspection readiness platforms. Why Join Arthrosi? • Opportunity to make a significant contribution to addressing a disease with significant unmet medical need., • Opportunity to make a significant impact in a small, agile organization advancing a promising late-stage oral therapeutic., • Dynamic and collaborative environment where science, innovation, and execution come together., • Competitive compensation and equity participation with high-growth potential., • Flexible work model and a mission-driven culture anchored in scientific excellence and patient impact.

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Sr Director, Quality Assurance is a strategic leadership role responsible for overseeing all aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering’s ongoing development programs with local, state, federal, and international requirements. This position will be instrumental in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop, implement, and maintain GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance · Lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. · Work with the company’s external suppliers and contract organizations to ensure consistent quality and compliance. · Prepare for and lead inspections by regulatory agencies and commercial partners, serving as the liaison between the Company and auditors, including reporting and follow-up to any finding · Oversee qualification and validation plans, assure proper batch releases and disposition. · Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA) · Provide quality input on contracts and serve as the point person for negotiation of quality agreements. · Champion a culture of quality and continuous improvement across manufacturing and development operations. Desired Skills and Qualifications · Bachelor’s degree in biological sciences or related field, with at least 8 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry · Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements · Demonstrated leadership experience managing teams and complex projects. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Supply Chain Manager Location: Onsite - Atlanta, or San Diego Salary Range: $80,000 - $120,000 Job Overview The Supply Chain Manager oversees supply chain and logistics operations to ensure efficiency, productivity, and compliance within the pharmaceutical manufacturing industry. This role involves developing strategies, monitoring performance, and implementing policies to optimize processes, reduce costs, and align supply chain activities with company objectives and regulatory standards. Key Responsibilities • Strategic Planning: Design and implement supply chain strategies to meet company goals, forecast demand, and adapt to market changes., • Operations Management: Oversee procurement, production, warehousing, and distribution, ensuring seamless operations and optimized workflows., • Vendor Relations: Manage supplier relationships, negotiate contracts, and evaluate performance for quality and cost-effectiveness., • Inventory & Demand: Maintain optimal inventory levels, implement control techniques, and align production with customer trends., • Logistics: Coordinate transportation and work with third-party logistics (3PL) providers to ensure timely deliveries., • Cost Management: Monitor costs, create budgets, and implement savings strategies while maintaining quality standards., • Data Analysis: Analyze supply chain performance metrics and recommend process improvements., • Risk Management: Identify risks, ensure regulatory compliance, and enforce health and safety policies. Education & Experience: • Bachelor’s degree in Supply Chain, Logistics, Business, or related field., • Strong knowledge of supply chain processes, logistics, compliance, and quality assurance., • Proficiency in ERP and supply chain software (e.g., SAP, Oracle)., • Excellent organizational, project management, and leadership abilities., • Advanced Education & Certifications: Master’s degree or certifications such as CPIM, CSCP, or CLTD., • Industry & Regulatory Knowledge: Familiarity with FDA, GMP, and ISO 13485 regulations. Experience in global logistics and applying lean supply chain principles., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description Principal Scientist, Toxicology - Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below. Immediate opening for a Principal Scientist, Toxicology in San Diego, CA who possess: • Ph.D. in Toxicology, Pharmacology, or a related scientific discipline., • Minimum of 5–7 years of experience designing, directing, and interpreting GLP toxicology studies, preferably within a CRO environment. Demonstrated record of serving as Study Director for multiple GLP studies, with completed studies that contributed to successful FDA submissions., • Experience preparing or contributing to IND/NDA/BLA nonclinical packages, with familiarity interacting with FDA, • DABT Certification is strongly preferred Email resumes to and call 858.427.3668. FULL DESCRIPTION: The Principal Toxicologist serves as the primary scientific expert and client-facing lead within our preclinical research group. You will design, oversee, and interpret a broad range of GLP-compliant toxicology studies for pharmaceutical and biotechnology partners. You will also be responsible for leading multiple GLP studies as Study Director, ensuring data integrity, study execution, and scientific interpretation that support regulatory submissions including IND, NDA, and BLA. The right candidate will have demonstrated success in navigating FDA expectations, preparing high-quality nonclinical packages, and contributing directly to regulatory approvals. The selected candidate will be responsible for: • Scientific Strategy and Client Partnership, • Serve as the principal scientific contact for clients, building long-term partnerships grounded in trust, transparency, and technical excellence., • Collaborate with clients to understand program objectives, ensuring study designs reflect both regulatory expectations and drug development goals rather than generic service deliverables., • Develop scientifically rigorous and customized toxicology study designs that align with FDA guidance, ICH expectations, and clinical-stage needs., • Study Oversight and Execution, • Function as Study Director for GLP toxicology studies, with responsibility for scientific conduct, data accuracy, final reporting, and regulatory readiness., • Maintain a strong portfolio of completed studies, demonstrating consistent success from protocol development through final reporting and client delivery., • Lead cross-functional coordination across in vivo and in vitro operations to ensure efficiency, consistency, and GLP compliance., • Monitor study performance proactively to identify risks, troubleshoot issues, and maintain timelines., • Data Analysis and Reporting, • Integrate toxicology, pathology, and clinical pathology data to generate meaningful, defensible conclusions for regulatory and scientific purposes., • Prepare, review, and sign off on high-quality study reports that accurately reflect study outcomes and support regulatory submissions., • Communicate study findings clearly and confidently in client meetings, regulatory interactions, and technical presentations., • Regulatory and Quality Assurance, • Ensure all studies are performed in full compliance with FDA GLP regulations and applicable international guidelines (e.g., ICH, OECD, ISO 10993)., • Support clients by authoring or contributing to nonclinical sections of IND, NDA, and BLA submissions, leveraging direct experience with FDA expectations., • Represent our Research during audits and health authority inspections, providing scientific and regulatory justification for study decisions and data integrity. The selected candidate will also possess: • Ph.D. in Toxicology, Pharmacology, or a related scientific discipline., • Minimum of 5–7 years of experience designing, directing, and interpreting GLP toxicology studies, preferably within a CRO environment., • Demonstrated record of serving as Study Director for multiple GLP studies, with completed studies that contributed to successful FDA submissions., • Experience preparing or contributing to IND/NDA/BLA nonclinical packages, with familiarity interacting with FDA or supporting sponsor regulatory strategy., • Proven ability to distinguish between CRO service execution and the strategic, milestone-driven requirements of drug development., • D.A.B.T. certification strongly preferred (or active pursuit/eligibility). Salary Range: $160-210k/year For immediate and confidential consideration, please email your resume to and call 858.427.3668. More information can be found at Company DescriptionSimply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Job DescriptionDescription: SUMMARY The Clinical Trial Assistant (CTA) will provide administrative support to the Clinical Operations Team in full spectrum of clinical trial activities related to study start up, study maintenance, study closure and vendor management in compliance with Good Clinical Practice (GCP), Standard Operation Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. ESSENTIAL DUTIES AND RESPONSIBILITIES The main responsibilities of this role include but are not limited to the following: • Assist with review, formatting and finalizing clinical protocols and other key study documents such as reports, Study Master ICF Template, etc., • Provides administrative support with various tasks such as review and formatting of documents including follow-up on various tasks, updating project timelines, etc., • Performs other duties as required. Requirements: EDUCATION AND EXPERIENCE REQUIREMENTS • Bachelor’s Degree in a related field., • Preferred but not required, minimum of one-year relevant clinical trial experience in the pharmaceutical and/or biotechnology industry., • Preferred but not required, prior experience as a CTA and/or knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements and clinical trials operations. KNOWLEDGE AND SKILLS REQUIREMENTS • The scope of this position requires strong organizational, communication, and administrative skills including proficiency in Microsoft Office Suite such as Word, Excel, PowerPoint., • Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential., • Requires good organization, documentation and interpersonal skills., • Ability to work independently as well as within a team-oriented environment., • Strong attention to detail. 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.

Job Description We are a growing pharmaceutical/medical device company specializing in polymer-based drug delivery systems actively seeking an experienced Analytical Chemist to join our Quality Control team. Key Responsibilities • Independently perform analytical testing on polymers, monomers, raw materials, and finished drug products using HPLC, GPC/SEC, GC-MS, Karl-Fischer titration, and flow-through dissolution systems., • Conduct incoming inspection of raw chemical materials per established specifications and procedures., • Develop, validate, and execute test methods as needed., • Manage and coordinate internal and external analytical testing, including stability studies for polymer devices and drug products., • Generate Certificates of Analysis (CoA), product release documentation, and technical summary reports., • Provide analytical support to Quality Assurance and Manufacturing teams., • Maintain laboratory equipment, order supplies, ensure proper housekeeping, and oversee safe chemical waste disposal in compliance with safety standards., • BS in Chemistry (or closely related field) with a minimum of 3 years (preferably 5+ years) of hands-on analytical experience in the pharmaceutical or medical device industry. An equivalent combination of education and experience will be considered., • Proven expertise operating and interpreting data from HPLC, NMR, and Karl-Fischer instrumentation. Experience with GPC/SEC and GC-MS is highly desired., • Familiarity with ChemStation, Empower, or OmniSec chromatography data systems is a strong plus., • Working knowledge of cGMP, ISO 13485, and pharmaceutical analytical procedures., • Prior experience analyzing polymers or macromolecules is highly advantageous., • Excellent attention to detail, documentation practices (GLP/GMP), and technical writing skills., • Strong teamwork and communication abilities. If you thrive in a fast-paced, quality-driven lab and meet the above requirements, we'd love to hear from you!

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, • 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, • 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 DescriptionDescription: Experienced and professional Manger of Supply Chain who will be responsible for managing the GMP inventory and global logistics at Viking’s San Diego site. The Manager of Clinical Supply Chain will report to the Director of Clinical Supply Chain. The position is highly cross-functional and will work with Quality Control, Quality Assurance, CMC, development team, regulatory, and external vendors. The Sr Manager of Clinical Supply Chain will represent Supply Chain function for Viking to define and operationalize Supply Chain system, to support clinical material manufacturing globally, and to determine distribution strategy for the lifecycle of products from pre-IND through post launch. Essential Duties And Responsibilities The main responsibilities of this role include but are not limited to the following: • With minimal supervision, manage and support investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management, • Monitor inventory levels ensuring no shortage of IMP throughout the life of a clinical trial, • Manage of packaging and labeling/distribution vendors, including relationship management, • Manage preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, coordinating the origination, proofing, and translation of clinical study labels and generation, • Proactively identifying potential issues and developing mitigating actions, • Interpret clinical synopses and protocols to create clinical IMP demand forecasts, • Attend clinical study and cross functional meetings as needed, • Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions to global supply chain, • Manage clinical study close-out activities, including returned goods, reconciliation, and inventory destruction, • Support drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Clinical Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations), • Support temperature excursion processes are executed as required, • Support IRT System development. Lead development of user requirement specifications and management module(s) as applicable, • Various other duties as assigned Requirements: • Bachelor’s degree in Chemistry, Pharmacy or other relevant discipline., • 6+ years of industry experience in Supply Chain Operations., • Significant experience with global shipping and logistics of materials., • Experience working in an FDA-regulated environment is required., • Experience with establishment and maintenance of GMP quality-controlled storage, • Direct experience with importing/exporting documentation (permits, licenses, declaration letters) for global distribution of live virus banks, cell banks, and raw materials., • Direct experience with 3rd party vendors for shipping/logistics service, • Knowledgeable with cGxP as well as regulatory regulations and compliance requirements for the pharmaceutical industry., • Experience in reviewing and authoring SOPs related to CMC Clinical supply chain., • Experience in organizing and management of GMP warehouse inventory, specifically in the biotech/pharma/consumer goods industries., • Experience with Inventory Management Systems is a plus., • Technical working knowledge and/or experience in product packaging or design a plus., • Comfortable in a fast-paced, dynamic, and highly fluid company environment with minimal direction and able to adjust workload based upon changing priorities., • Strong computer skills with Microsoft Office and the ability to quickly learn new applications., • Team player with demonstrated strong communication skills, interpersonal skills, and ability to build effective working relationships throughout all levels of the organization. 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.

Job Description Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Quality Assurance is a strategic leadership role responsible for overseeing key aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering’s ongoing development programs with local, state, federal, and international requirements. This position will be supportive in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance · Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. · Work with the company’s external suppliers and contract organizations to ensure consistent quality and compliance. · Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding · Work on qualification and validation plans, assure proper batch releases and disposition. · Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA) · Provide quality input on contracts and serve as a point person for negotiations of quality agreements. · Champion a culture of quality and continuous improvement across manufacturing and development operations. Desired Skills and Qualifications · Bachelor’s degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry · Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements · Demonstrated hands on experience working on complex projects. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong partnering and communication skills required, as well as project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Pay scale: $175-210 annually, final offer to be commensurate with education and depth of experience, with potential for equity participation, bonus and comprehensive benefits. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company’s clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals. · Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA. · Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers. · Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts. · Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes. · Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings. · Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals. · Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO’s and consultants. Desired Skills and Qualifications · Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred. · Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job DescriptionDescription: The Quality Associate, Microbiology is responsible for performing routine environmental and utilities monitoring of the cGMP manufacturing facilities. Conducts microbiological and chemical testing including endotoxin, bioburden, total organic carbon (TOC), and conductivity to support product release and facility compliance. Additional responsibilities include assisting with data trending, supporting method validation activities, and contributing to 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 • Conduct Bioburden and endotoxin testing of in-process and products samples., • Perform environmental monitoring (EM) of classified cleanrooms and controlled areas., • Collect and test water samples from purified water and WFI systems., • Maintain accurate and compliant documentation in accordance with cGMP, GDP, and internal SOPs., • Assist in investigations of microbiological deviations and support CAPA implementation., • Collaborate cross-functionally with Manufacturing, QA, and Validation teams., • 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. JOB REQUIREMENTS Education and Experience • BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience., • 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).Requirements:

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Product Quality Specialist supports Capricor’s cell therapy programs by assisting in the implementation of cGMP requirements, regulatory expectations, and industry best practices. This role contributes to product quality activities that enable clinical and commercial production, including documentation review, investigation support, data trending, and coordination of quality processes. The position requires effective cross-functional collaboration across sites, program teams, and partner functions to help ensure products consistently meet established quality standards and organizational objectives. Responsibilities * Quality Management and Oversight: • Ensure cGMP compliance throughout all stages of product development, including clinical and commercial production., • Support investigations and provide quality oversight for deviations, CAPAs, OOS/OOT/invalid results, and change controls; ensure timely and effective root cause analysis., • Review product-related investigations and provide clear, well-supported assessments of product impact., • Act as the product quality steward, providing oversight of product quality trends, specifications, stability, and critical quality attributes (CQAs)., • Participate as a non-voting representative atMaterial Review Board (MRB) to provideproduct impact assessments and disposition recommendations., • Analyze product quality data to detect trends, variability, or emerging risks; recommend corrective or preventive measures as needed., • Oversee and maintain the lifecycle of product specifications, including justification, and revisions., • Collaborate closely with QC and analytical development teams to ensure sampling plans, test methods, and acceptance criteria remain appropriate and scientifically justified., • Provide Quality support for QC investigations, including OOS/OOT assessments, invalid results, and method performance trends., • Contribute to product-specific quality risk assessments (ICH Q9) covering CQAs, manufacturing controls, process risks, and testing risks., • Ensure product control strategies remain current, robust, and aligned with evolving process understanding., • Support stage-appropriate process validation and continued process verification activities, as applicable. Supplier and External Partner Management: • Support the quality oversight with contract testing labs, distributors, and other key external partners., • Participate in audits of third-party facilities as necessary to verify compliance with cGMP and regulatory requirements., • Serve as a subject matter expert and provide guidance to internal stakeholders on quality best practices, regulatory expectations, and cGMP requirements., • Support training initiatives and quality improvement projects that strengthen the organization’s culture of quality., • Collaborate cross‑functionally to uphold compliance standards. Basic Qualifications, • Bachelor’s degree in Life Sciences, Biotechnology, or a related field., • 4+ years of experience in manufacturing, process engineering, quality assurance or quality control, with a focus on biologics, cell therapy / advanced therapies, or similar fields within the biotech or pharmaceutical industry., • Strong knowledge of cGMP regulations, FDA/EMA guidelines, and ICH Q-series guidelines applicable to cell-based and biologic products., • Strong working knowledge of ALCOA+ and data integrity expectations., • Excellent written and verbal communication skills with a strong ability to present information clearly and logically., • Effective teamwork skills, ability to foster collaboration, and work effectively in a fast-paced, cross-functional environment., • Exhibits strong attention to detail and adherence to established QA procedures. Preferred Qualifications, • Experience with aseptic processing, sterility assurance, and quality control testing for cell therapies., • Experience supporting product quality in clinical and commercial settings, including batch release, deviation management, and regulatory inspections., • Experience supporting stability programs or specification-related documentation., • Hands-on experience with deviation management, CAPAs, and change controls, including drafting investigation summaries., • Familiarity with regulatory requirements for autologous and allogeneic cell-based / advanced therapies., • Experience reviewing or supporting trending of product quality data.

IT Project Manager – Pharma/Life Sciences Position Summary We are seeking an experienced IT Project Manager to lead technology initiatives supporting pharmaceutical, biotech, or life sciences operations. The ideal candidate will manage cross-functional teams, drive digital transformation, and ensure compliance with industry regulations (e.g., FDA, GxP). This role is responsible for delivering projects that enhance business systems, data integrity, and operational efficiency in a regulated environment. Key Responsibilities • Lead and deliver IT projects across clinical, commercial, R&D, or manufacturing domains within pharma/life sciences., • Oversee project planning, execution, and delivery, ensuring alignment with business objectives, timelines, and budgets., • Collaborate with stakeholders from IT, QA, regulatory, and scientific teams to define requirements and manage expectations., • Ensure all systems and processes comply with relevant regulations (FDA, GxP, 21 CFR Part 11) and support validation activities., • Manage risk, change, and incident/problem resolution throughout the project lifecycle., • Facilitate user acceptance testing, training, and documentation for new systems or upgrades., • Support process improvements and the adoption of best practices in IT service management (ITIL, Agile, Waterfall)., • Provide technical oversight for infrastructure, cybersecurity, and data management projects. Qualifications • Bachelor’s or Master’s degree in Computer Science, Information Technology, Life Sciences, or related field., • 4+ years of IT project management experience in a pharmaceutical, biotech, or life sciences company., • Familiarity with regulatory requirements (FDA, GxP, validation, 21 CFR Part 11)., • Experience with business systems (ERP, LIMS, CRM, clinical trial platforms) and supporting validation for regulatory purposes., • Project Management certification (PMP, Scrum Master) preferred., • Strong communication, leadership, and organizational skills., • Experience with project management tools (Jira, MS Project, ServiceNow, etc.) is a plus. Compensation: $60-$70/hour

Overview: Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Contract Specialist Position: Contract Specialist Location: San Diego, CA Duration: 6 months+ Contract with high possibility of extension!!! Pay Rate: $32/hr Note: • ONSITE role, • Work shift hours: Mon-Fri 7am-4pm, • The candidate must be organized and have good communication skills, • Extension possible and potential to convert to FTE Job Description: • Bachelor's degree required (relevant experience may substitute for educational requirement), • 1-3 years of general contract experience, • Proficiency in Microsoft applications and Customer Relationship Management software (e.g., MS Teams, Excel, SharePoint, Salesforce, and SAP), • Strong organizational skills (must be highly organized and detail-oriented), • Communication skills (including exemplary customer service practices), • The ability to successfully communicate at all business levels., • The ability to manage complex tasks and make independent recommendations., • A general understanding of a commercial contracting process, including contract strategy development, pricing, billing, invoicing, product technology, quoting, and policy development., • Excellent written and verbal communication skills Responsibilities include: • Interacting and proactively communicating with multiple MMS Dispensing teams, • Audit review of all components submitted as a complete contractual package., • Executing complete contractual packages, • Maintaining an up-to-date knowledge of product offerings, policies and procedures, and purchase acquisition/marketing programs, • A working knowledge of US Antitrust laws, HIPAA laws, Sarbanes Oxley rules, Internal Audit procedures, and regulatory controls, • A working knowledge of both the pre- and post-signature capital contracting processes including, but not limited to, acceptance and performance, product installation, billing/revenue management, leasing and purchasing, and asset management and how each are related., • A general understanding of capital equipment revenue recognition guidelines and accounting principles, • A general understanding of contract review, risk mitigation, and regulatory compliance, including, but not limited to, evaluating, and enforcing all necessary and required pre-execution requirements, and the ability to escalate when necessary. Thanks! GURJANT "GARY" SINGH | LEAD RECRUITER Office 925.297.5994

Job DescriptionOur client is a top ENR General Contractor immediately looking for a Senior Superintendent to lead $100M+ life science projects in the San Francisco Bay area. The Sr Superintendent supervises the field construction of a single large or complex project or multiple projects, including organization, planning, and scheduling, in order to complete the work on time, within budget, and to quality specified. What You'll Need • Life science, Bio- tech, Lab, Clean room, Pharmaceutical, or medical manufacturing project experience with values over $100M, • Proficient knowledge and use of Primavera P6 scheduling software required., • Proficient in all aspects of building systems., • Thorough knowledge and understanding of the general and subcontract documents, drawings and specifications, construction means, methods and materials, understanding of line and grade and survey methods., • Proficient knowledge of building codes and compliance., • Proficient knowledge of construction cost control and accounting procedures., • Primary liaison with owners/architects/engineers for the day-to-day construction activities of the project., • Participate in project pursuits, proposals and presentations. Main contributor in securing the project during the competition phase., • Lead, supervise and develop Superintendents and other staff, including providing input on or complete performance appraisals., • Develop and implement overall project set-up and site logistics plan and identifying project-specific scope of work to implement the plan., • Develop and implement overall project work schedules identifying the critical path including the expediting of scheduled critical materials and equipment for their timely delivery to site., • Review and respond to subcontractor schedule impacts and or claims of productivity impacts., • Ensure strict adherence to ethics and compliance requirements at all times., • Develop and manage the overall site safety program as required and ensuring subcontractor compliance with company standards and all applicable safety codes and regulations., • Manage and make decisions related to the performance of work related to scheduling, delivery, logistics, quality control and trade employee staffing levels., • Document project field issues that impact budget, quality or schedule., • Respond to subcontractor requests for field issues that impact budget, quality or schedule., • Oversee work among all trades to promote a coordinated project operation. Resolve local area problems, regarding procedures, precedence, design clarifications, adequate labor and equipment, schedule and all other appropriate matters., • Manage labor relations with subcontractors and trade staff.Benefits, • Health, medical, dental, and vison insurance, • HSA/ FSA, • 401 (k) plan, • Paid vacation and holidays, • Project bonuses

Job DescriptionThe Senior Manager of Supply Chain will be responsible for the strategic operational oversight of all aspects of clinical supply chain to ensure timely drug supply for Janux’s clinical programs. Reporting into the Director of Supply Chain, this role will also collaborate with other functions within CMC, Clinical Operations, Regulatory and Quality Assurance (QA) to forecast and support clinical trial supply requirements including clinical drug manufacturing schedules and inventory, packaging, labeling, and distribution activities.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Prepare, maintain, and periodically re-evaluate demand forecasts and supply strategies to ensure uninterrupted IMP supply to clinical sites while minimizing product waste throughout the clinical trial., • Contribute to and review Interactive Response Technologies (IRT) specifications; manage IRT systems in alignment with the overall supply strategy., • Collaborate with cross-functional teams to create and approve labeling designs in compliance with regulatory requirements., • Manage packaging activities at the Clinical Packaging Organization (CPO) and coordinate with QA for release., • Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records., • Oversee distribution and inventory of clinical trial material across depots and sites., • Manage drug return, destruction process, and accountability at the depots., • Coordinate material shipments from CDMO to storage facilities and CPOs., • Review and approve third-party vendor invoices, ensuring accuracy and compliance with contractual terms., • Partner with QA on quality events, investigations, deviations/CAPA, batch record review and drug disposition., • Manage expiry date extensions, documentation, and related distribution activities., • Participate in forecast meetings with Clinical Operations. Prepare presentation materials and communicate inventory updates and operational strategies., • Identify and lead process improvement initiatives to enhance efficiency and compliance., • Perform other responsibilities as assigned.REQUIRED SKILLS AND QUALIFICATIONS, • Bachelor’s degree in a scientific or pharmaceutical discipline., • 6+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management., • Inventory management and vendor oversight experience in all phases of drug development for biologics with global clinical supply distribution is required., • Strong knowledge of cGMP, GCP regulations, and Annex 13 and VI., • Solid understanding of clinical research protocol requirements and experience developing IRT specifications., • Familiarity with biologics manufacturing processes is highly desirable., • Experience with logistic systems and shipping required., • Effective communication and direction., • Ability to identify project risks and rapidly develop and implement risk mitigation strategies in a fast-paced environment with changing priorities.In addition to a competitive base salary ranging from $164,000 to $173,000, we offer stock options, 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:· 401K· Medical insurance· Dental insurance· Vision insurance· Supplemental disability insurance plans· Flexible schedule· Life insurance· Flexible vacation· Sick time· Incentive stock option plan· Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. 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 DescriptionJanux Therapeutics is seeking a strategic and accomplished Senior Talent Acquisition Specialist to drive our recruitment efforts in a dynamic, high-growth biotechnology environment. As a key partner to our Talent Acquisition and Human Resources teams, you will own the full lifecycle of talent acquisition, shaping and executing strategies that attract, engage, and secure top-tier talent aligned with Janux’s mission and values. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Architect and implement recruitment plans to source exceptional candidates for a diverse range of roles, leveraging deep industry knowledge and innovative sourcing techniques., • Manage a portfolio of open requisitions, overseeing every aspect of the process: job description development, targeted outreach, rigorous resume screening, advanced interview methodologies (virtual and on-site), candidate and stakeholder communications, offer negotiation, and seamless onboarding., • Cultivate and optimize sourcing channels—including social media, professional networks, and specialized job boards—to identify and engage high-caliber talent., • Build and maintain strategic relationships with placement agencies, contract recruiters, and external partners, ensuring a consistent and compelling employer brand presence across all recruiting campaigns., • Oversee the Applicant Tracking System (ATS), ensuring compliance with Janux and regulatory standards, and deliver actionable insights through robust reporting on hiring trends, turnover, and candidate experience., • Champion diversity, equity, and inclusion initiatives throughout the recruitment process, fostering a culture of belonging and innovation., • Serve as a trusted advisor to hiring managers and senior leaders, providing market intelligence and guidance on talent strategy., • Handle sensitive and confidential information with the utmost discretion and professionalism., • Adapt and thrive in a fast-paced, rapidly evolving environment, continuously seeking opportunities to enhance recruitment processes and outcomes.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Bachelor’s degree in human resources, business administration, or a related field., • Minimum of 7 years’ progressive experience in talent acquisition or recruitment within the biotechnology or pharmaceutical sector; agency experience is highly valued., • Demonstrated expertise in all facets of talent acquisition, including workforce planning, employer branding, and advanced interview techniques., • In-depth understanding of the unique practice areas within a growing biotechnology organization., • Mastery of Applicant Tracking Systems (ATS), HR databases, and recruitment analytics., • Comprehensive knowledge of employment laws, regulations, and compliance standards., • Proven success in designing and executing recruitment strategies., • Exceptional verbal and written communication skills, with the ability to influence and engage stakeholders at all levels., • Track record of success in high-growth, fast-paced environments.Compensation:In addition to a competitive base salary of $130,000 - $150,000, 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, and internal equity.Job Type: Full-time Benefits:· 401K· Medical insurance· Dental insurance· Vision insurance· Supplemental disability insurance plans· Flexible schedule· Life insurance· Flexible vacation· Sick time· Incentive stock option plan· Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. 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 DescriptionFront Office Associate About Human Longevity Inc. Human Longevity, Inc. (HLI), is a privately held human health information technology and health care company founded by pioneers in the fields of genomics and stem cell therapy to revolutionize human health and the practice of medicine. Using advances in genomic sequencing, the human microbiome, metabolomics, informatics, computing, and cell therapy technologies, HLI is building the world’s most comprehensive knowledge base of human genotypes and phenotypes as a basis for a variety of opportunities to help solve aging related disease and human biological decline. Clients have access to state of the art physiologically quantitative clinical and behavioral testing that includes whole body MRI, 4D echocardiography, advanced biometric analysis, and wireless digital monitoring that will serve as the basis of a truly personalized approach to health and longevity care. We are committed to revolutionizing human health and the practice of medicine. Purpose of Job The Human Longevity Front Office Associate is a client facing position, ensuring efficient office operations and client satisfaction. The primary duty of this position is to support the scheduling of client appointments, coordinate client visits, order and deliver meals, as well as provide administrative support to the Medical team. Tasks and Responsibilities • The Care Concierge will reach out to clients ahead of their visit to provide a clear overview of HLI’s value propositions — including product details, technology differentiation, process workflows, and post-test expectations — ensuring a seamless and personalized client experience., • Acts as the primary liaison between the commercial and clinical teams, managing onboarding, scheduling, and coordination for new and returning clients., • Supports client retention efforts by building strong relationships, maintaining regular touchpoints, and ensuring that each client feels engaged and valued throughout their membership journey., • Coordinates with the clinical team to confirm client dietary preferences or special needs and ensures these are accommodated appropriately during the visit. Prepares client suites according to individual preferences and serves as the client’s key on-site contact on the day of their visit, ensuring a warm, professional, and welcoming experience., • Works closely with clinical staff to coordinate testing flow, minimize downtime, and maintain a consistent, relaxing room environment for each client., • Assists with operational tasks such as scheduling results reviews, managing trackers, and supporting other workflow needs as assigned., • Schedules follow-up appointments and Care System Backlog appointments in collaboration with the clinical and operations teams to ensure timely continuity of care., • Maintains and submits accurate records of clinic credit card purchases, ensuring compliance with financial tracking and reporting procedures., • Manages and tracks blood draw–related activities, including test requisition forms (TRFs), inventory management, and sample logistics when needed., • High School diploma or equivalent, • Experience in client-facing environments, • Exceptional verbal and written communication skills with ability to adapt quickly, • Strong organizational and multi-tasking skills, • Demonstrated ability to work in confidential environments and operate with the utmost discretion, • Resourceful problem solver with careful attention to detail and consistent follow-through, • Ability to work independently and prioritize objectives throughout day in fast-paced environment, • Ability to work well with teams in an open environment, • Bachelor’s degree, • Experience in biotechnology, pharmaceutical or healthcare settings, • Experience with Allscripts and/or Outlook, • Open clinical environment, • Prolonged periods of sitting, standing, bending and kneeling SLthl1WWYz

Remote - Nationally Sourced, prefer candidates located in PST with Remote work experience Monday Friday (8 AM to 4:30 PM). No overtime and flexible on the start/end time. Duration: 6+ months Job Description: Perform duties to support the efforts pharmacy department in the development, coordination and maintenance of the health plan's pharmacy program. Education/Experience: High school diploma or equivalent. 3+ years of pharmacy experience, preferably in a managed care environment. Medicare and/or Medicaid experience preferred. Responsibilities Receive and respond to provider and pharmacy calls regarding the prior authorization and formulary process Perform review of pharmacy and override process in compliance with pharmaceutical related company and State guidelines Track and trend overrides to ensure criteria have been met, audit for prior authorizations, analyze cost and determine utilization patterns Resolve complaints and grievances related to the pharmacy network in conjunction with the Pharmacy team Assist Provider Relations and various departments with educating providers on the health plan s pharmacy process Assist with the pharmacy utilization review and reporting process Collaborate with Quality Improvement department with various meeting preparation and transcription of minutes Assist with members inquiries related to the formulary process Performs other duties as assigned. Typical Day in the Role • Walk me through the day-to-day responsibilities and a description of the project (Outside of the Workday JD)., • What are the performance expectations/metrics? Follow training instructions and complete training sessions in a timely manner. Expectation will be to maintain high-quality level work. Pay close attention to details. Complete monthly configuration on time. Candidate Requirements Education/Certification Required: high school diploma Preferred: Licensure Required: NA Preferred: prefer a Pharmacy Technician License but not required. Years of experience required: 3+ years of Pharmacy Technician experience (open to PBM, retail, or other various experience) Disqualifiers: Additional qualities to look for: Ability to multitask or properly prioritize work, Experience with projects or assignments that require attention to details. • Top 3 must-have hard skills stack-ranked by importance 1 Pharmacy Technician experience (open to PBM, retail, or other various experience) 2 Microsoft Office Experience Excel, Word, Outlook, Visio 3 Ability to work independent and keep good communication with about their project/assignment updates.

IT Project Manager Pharma/Life Sciences.We are seeking an experienced IT Project Manager to lead technology initiatives supporting pharmaceutical, biotech, or life sciences operations.The ideal candidate will manage cross-functional teams, drive digital transformation, and ensure compliance with in

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 CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. Essential Duties and Responsibilities: • Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development., • Represent GPV in communication with health and regulatory authorities., • Represent GPV at independent Data Safety Monitoring Committee meetings., • Provide medical oversight of the GPV function including medical review of all cases., • Provide medical input for maintaining REMS, RMP safety monitoring commitments., • In collaboration with other members of GPV, create and maintain a signal detection process for Erasca's products with a clearly defined signal detection strategy for each asset., • In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments., • Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems., • Provide periodic benefit-risk assessment reports for internal use., • Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities., • Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc)., • Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates., • Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis., • Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources., • Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met., • Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors., • Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs., • Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered., • 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred., • Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications., • In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation., • Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred., • Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred., • In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases., • Direct management experience with proven ability to effectively lead, coach, mentor, and manage others., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment., • Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. 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.