Pharmaceutical jobs in San Diego, California - Page 2Create job alerts

A leading international pharmaceutical company is seeking a Senior Medical Science Liaison for the San Diego region.

Position Overview We are seeking an experienced and visionary Vice President of Business Development, Services & Partnerships to lead strategic growth initiatives with biotech and pharmaceutical partners. Vice President of Business Development, Services & Partnerships Join to apply for the. This rol

Get notified about new Business Development Manager jobs in. Position Title: Business Development Manager, U. At least 1 year of experience in overseas business development, sales, or partnership expansion, with a background in antibody CROs or pharmaceutical companies preferred.

We are excited to announce an opportunity for a dynamic Business Development Manager to join a premier organization in the field of drug discovery. Understand and navigate the academic, biotech, and pharmaceutical markets to identify and capitalize on business opportunities. Strong expertise in synt

Technology & Life Sciences offers a wide array of products to technology software and service providers, electronics manufacturing companies as well as medical technology and pharmaceutical companies. The Account Executive (AE), Technology will partner with agents and brokers to provide coverage for

The ideal candidate will bring strong leadership, organizational expertise, and deep industry knowledge across the pharmaceutical, biotech, or medical device sectors, along with a proven track record of success in previous roles. Previous experience that provides the knowledge, skills, and abilities

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead's standards for accuracy, clarity, compliance, and scientific integrity. The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs. Responsibilities • Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas., • Perform QC activities (editing and data verification) for clinical and regulatory documents, including but not limited to clinical study protocols and amendments, Investigator's Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books., • Collaborate with lead medical writers and subject matter experts to identify and obtain appropriate QC source materials., • Manage external QC vendors to ensure consistent, high-quality deliverables when additional support is required., • Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead's expanding pipeline., • Support planning and content development for document kick-off meetings, including slide deck preparation as needed., • Bachelor's degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master's or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry., • Exceptional attention to detail, with the ability to identify issues in complex scientific documents, • Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing, • Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments, • Ability to manage multiple priorities while maintaining high-quality standards, • Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint), • Familiarity with basic statistical concepts is a plus All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Senior Director, Pharmaceutical Development Team Leader (PDTL). The Senior Director, Pharmaceutical Development Team Leader (PDTL) is responsible for developing and leading the execution of comprehensive, compound-specific Technical Operations strategies to meet the global project team's (GPT) needs

Business Development Representative/h2pThe incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particularly to support the growth of emerging Discovery oligonucleotid

A biotechnology firm located in San Diego, California, is seeking a Director of Quality Assurance to lead the QA function. Candidates should have at least 7 years of experience in Quality Assurance within the pharmaceutical or biotech sectors and possess extensive knowledge of GxP regulations. The r

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Biochemistry Intern will support drug discovery efforts at Arrowhead Pharmaceuticals by contributing to laboratory-based process improvement projects that help accelerate drug development. This internship offers hands-on experience performing experiments and supporting workflows that enable faster discovery of new drug candidates and therapeutic platforms. The intern will work as an integral member of a multidisciplinary research team and gain practical exposure to molecular biology, protein science, and laboratory operations in a pharmaceutical research environment. This is an 11-week Summer Internship Program paying $24.00 per hour and requires full-time, onsite work five days per week at the designated location. Responsibilities • Design and support plasmid constructs and perform DNA preparation., • Perform mammalian cell culture, including protein and antibody expression and purification., • Conduct protein and antibody characterization and validation using molecular biology techniques., • Maintain accurate and up-to-date experimental records in a laboratory notebook., • Support process improvement experiments aimed at increasing efficiency and speed in drug discovery workflows., • Collaborate closely with a multidisciplinary research team to support project goals., • Currently enrolled student at an accredited university or college, majoring in Chemistry, Engineering, Biology, or a related scientific discipline., • Basic knowledge of ELISA, molecular biology techniques, and protein expression and purification., • Interest in drug discovery, process development, or biotechnology research., • Excellent verbal and written communication skills., • Strong problem-solving and analytical skills., • Demonstrated eagerness to learn new laboratory techniques., • Curiosity, attention to detail, and enthusiasm for hands-on experimental science., • Excellent organizational skills and ability to manage multiple tasks or projects. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

The Director of Digital Systems Quality Assurance (DSQA) is responsible for establishing, leading, and continuously improving the quality oversight of GxP digital systems supporting gene therapy manufacturing, pharmaceutical development, and analytical laboratories. Role-related knowledge: Working k

Job Description Veterinary Technician – GP/Urgent Care - Carmel Valley Papaya Veterinary Care is looking for Veterinary Technician candidates for our GP/Urgent Care hospital in Carmel Valley (San Diego). We are a transformative veterinary hospital that offers an elevated level of care to both our patients (fur babies) and caregivers (clients). At Papaya Veterinary Care, our mission is to disrupt the current standard that falls short in providing thorough, available, and continuous care. We take pride in providing brand new state-of-the-art facilities, medical care led by experienced doctors, and a team of passionate technicians dedicated to delivering the highest level of care possible. By providing a positive and healthy work culture for our staff, we can commit to creating an exceptional and uplifting experience for all our clients, patients, and employees. Our hospital is in one of San Diego County's premier shopping centers, Pacific Highlands Ranch. During our days off and after work, our team loves to embrace the outdoor lifestyle that San Diego County offers. You can often find us cycling, hiking, surfing, indulging in wine tasting, camping, and simply relaxing on the beach. We share a common passion for animals and thrive in a collaborative environment. If you are looking for an elevated experience in Veterinary Care, you have come to the right place! Duties and Responsibilities: • Assist doctors/RVTs with their outpatient cases and hospitalized patients., • Provide outstanding client communication and education., • Give feedback and receive constructive criticism in real time., • Maintain safe, clean environments., • Adaptability to an ever-changing environment, where urgent or emergent cases will be taken as they arrive., • Provide empathetic and helpful interaction to clients, vendors, peers, and managers., • Provide solid technical skills including but not limited to various blood draw techniques, IV catheter placement, administering drugs various routes, medication calculations, knowledge of pharmaceutical drugs, proper patient handling and housing., • Have sound judgement regarding prioritization, next steps and in communication with clients, vendors, and peers., • Function independently and with a team., • Advocate for the patient while providing exceptional comfort, diagnostic, surgical, and nursing care to all patients., • Minimum of 3 years in veterinary medicine, • Comfortable with front and back-office procedures, • Strong communication skills, verbal and written; organizational skills; proactive thinking and a positive attitude are also a must., • Willing and able to work in an ever-changing environment., • Self-starters, compassionate and team-oriented people with a positive attitude and strong work ethic, • Working in brand new facility with state-of-the-art equipment, • Pet Care Discount Employment is “at will. Job Type: Part-time Salary: $22- 24 per hour Schedule: 8-hour shift, weekend availability (Saturdays) - Fridays and Saturdays Education: High school or equivalent (Required) Work Location: In person Powered by JazzHR PznUGmE2jO

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. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Therapeutic Specialty Representative San Diego, CA The Role As a Therapeutic Specialty Representative (TSR), youll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue. As a Therapeutic Specialty Representative (TSR), you will educate healthcare providers on how Anaphylm is designed to address barriers that prevent patients from carrying and administering epinephrine, building trusted relationships to drive adoption of Anaphylm. This role is ideal for ambitious sales professionals who thrive in a launch environment and who want their work to have genuine clinical impact. Key Responsibilities Strategic Territory Development Design and execute territory business plans that identify high-potential accounts and drive measurable market penetration Analyze prescribing patterns, payer landscapes, and competitive dynamics to prioritize efforts and maximize ROI Partner with Regional Sales Managers to align field execution with broader commercial strategy Clinical Education and Relationship Building Deliver compelling, compliant clinical presentations that demonstrate Anaphylm's value in addressing unmet patient need Build trust-based relationships with key prescribers, practice administrators, and healthcare stakeholders through consistent engagement and authentic dialogue Navigate complex clinical objections with insight and empathy, positioning Anaphylm as the solution to real-world challenges Access and Pull-Through Excellence Master payer coverage dynamics across your territory—national, regional, and local insurance landscapes Collaborate with Market Access, to overcome prior authorization barriers and ensure seamless patient onboarding Drive formulary wins and in-office pull-through by equipping providers with the tools and knowledge they need Flawless Execution Orchestrate high-impact customer engagement programs including lunch-and-learns and speaker events Maintain CRM excellence: capture detailed call notes, payer feedback, sampling activity, and strategic next steps with precision Ensure 100% compliance with PDMA sampling requirements, AE/product complaint reporting, and promotional guidelines Field Intelligence Serve as the eyes and ears of the organization, sharing customer insights, competitive intelligence, and best practices that inform strategy Contribute to a culture of continuous learning and improvement across the sales organization Qualifications Required Bachelor's degree 3+ years of pharmaceutical, specialty, or B2B sales success with proven track record of exceeding targets Deep understanding of payer coverage, prior authorization workflows, and access barrier navigation Strong analytical skills with demonstrated ability to translate data into actionable territory strategies Willingness to travel overnight 50% for customer meetings, conferences, and sales meetings Preferred Launch experience in specialty or allergy markets. Specialty pharmacy or hub services background Experience selling products that address medication adherence or administration barriers

Job DescriptionFate Therapeutics is seeking a hands-on physician leader to serve as Medical Director within Fate’s Clinical Development Group. This individual will contribute to the development and implementation of clinical strategies and may be responsible for the oversight of contracted personnel and or organizations to advance Fate’s clinical program(s). They will also serve as a liaison between Fate and clinical investigators and will need to maintain established and productive relationships with key opinion leaders (KOL), as well as regulatory officials. The ideal candidate should have experience in solid and hematologic tumor oncology, with experience in the design and conduct of clinical studies in this therapeutic area. Experience with cellular therapies is desirable. This is a full-time exempt position located at our corporate headquarters in San Diego, CA.Responsibilities • Provide clinical leadership of one or more programs across solid and hematological tumors., • Design competitive clinical strategies and deliver effective and timely study protocols in collaboration with clinical investigators, key opinion leaders and regulatory agencies to meet Fate scientific and corporate objectives., • Prepare study protocols, amendments, specific sections of study manuals, Investigator Meeting notebooks, and other documents with appropriate guidance and supervision., • Contribute to start-up activities, including the design and development of CRFs, Data Management Manuals, and Data Analysis Plans., • Address questions regarding scientific and related procedural issues from internal and external parties regarding assigned studies and programs., • Contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, scientific presentations, as well study close-out activities., • Assist in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs., • Play a leading role in the development and implementation of communications strategies to support existing and concluded studies., • May enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development., • Consistently comply with all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines., • Maintain effective working relationships with team members to ensure scientific integrity of clinical studies., • May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.Qualifications, • MD degree with 5+ years of relevant scientific and/or drug development experience., • 2+ years in clinical research in a pharmaceutical company, contract research organization, or academic institution is preferred., • Experience in oncology is required., • Demonstrated ability to be flexible and adaptable to change., • Ability to form effective working relationships with internal and external parties including investigators, KOLs, Clinical Sites, etc., • Outstanding written communication skills., • Strong presentation skills; highly effective at summarizing and presenting the key considerations and decision-points.Working conditions & physical requirements, • Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels., • Travel may be required. Compensation, • The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location., • Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. ⚠️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud:- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.- We will only ask for personal information when applying for a position via our Careers page or thereafter.- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. 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 DescriptionSummary Our client, a top notch mechanical contractor, is currently seeking an experienced Plumbing Estimator for their San Diego, CA location. Backed by the strength and stability that comes with almost a century of customer care and ownership, they adhere to the highest safety standards for its employees and clients. They offer industry-leading building information modeling (BIM) capabilities, design/build services, sustainable solutions, commercial HVAC services, and complex mechanical and industrial system installations. Plumbing estimator is responsible for all phases of the estimating and bidding process including preconstruction services and performing estimate takeoffs. Thorough knowledge of the mechanical construction bidding processes is required. Specific expertise with Plumbing systems serving hotels, student housing, laboratories, power plants, Cogeneration facilities, manufacturing facilities, clean rooms, cGMP facilities and process systems for Pharmaceutical and microelectronics facilities is desired. Ability to produce a complete detailed estimate from incomplete design documents is preferred. Duties And Responsibilities Bid document review, pre-bid meetings, client interface, quantity takeoff, material, equipment and subcontractor pricing, spreadsheet input and proposal preparation. Estimates will be prepared using Quote Express estimating software. Experience with Quote Express or other on-screen estimating software is desired. Duties also include on site and/or In-house estimating where candidate will work with professionals in design firms on design-assist and design-build projects to direct the design to meet the budget. Estimator will also interface with construction project teams and CAD detailing staff. Must have knowledge regarding safety, workers compensation, insurance and bonding, materials as it pertains to bidding requirements. Other duties may be assigned. Qualifications Computer Skills Proficient in MS Word, MS Excel, Bluebeam, Internet, Lotus Notes, and QuoteExpress windows-based piping and sheet metal estimating systems. Required Attributes Must possess excellent written and verbal communications skills.Maintain a professional manner in actions and appearance when representing the organization.Must prioritize in a fast paced multi-task environment with organization skills.Must have demonstrated ability to perform basic business mathematical functions.Must work with minimal supervision.Must effectively manage time and details.Must interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Must have organizational skills in handling & archiving technical data.Must comply with all operating policies, procedures, plans, and programs. Prefer a minimum of 3-5 years mechanical construction experience and proficiency in the preparation of large and complex bid proposals of all types. Language Skills Must have the demonstrated ability to effectively communicate, cooperate, and collaborate with multiple levels of employees, vendors, and suppliers. Employment Type: Full time Location: San Diego, CA

Job DescriptionSummary: The Senior Research Associate, Protein Sciences will play a key role in advancing our mission to develop novel therapeutics for cardiometabolic diseases. This position will primarily support the expression and purification of therapeutic candidates and assist with molecular cloning efforts, as well as analyze and present data and contribute scientific insights to drive our research forward. The Senior Research Associate will collaborate closely with cross-functional teams to accelerate progress, delivering reproducible, reliable data and solutions that help move promising therapies closer to patients who need them most. • Manage the expression and purification of proteins in mammalian cell systems, supporting multiple teams and molecular biology efforts as needed., • Develop and employ processes to produce endotoxin-free material., • Operate and maintain relevant laboratory equipment including incubators, biosafety cabinets, FPLCs, and other related instruments., • Review and contribute to the creation and revision of SOPs related to expression and purification practices and maintain accurate reporting in an electronic lab notebook system., • Knowledge of mammalian cell transfection techniques, especially lipofection, for CHO and HEK293 cells., • Familiarity with chromatography techniques such as protein A, ion exchange, Ni-NTA, and desalting., • Knowledge of endotoxin-removal procedures and methods for maintaining instrumentation to prevent endotoxin contamination., • Experience with FPLC operation and troubleshooting, particularly using ÄKTA Avant or ÄKTA Pure systems.Experience with molecular biology techniques, including cloning (restriction enzyme digestion/ligation, Golden Gate assembly, or Gibson assembly), bacterial transformation and culture, and DNA preparation and characterization., • Strong analytical and problem-solving skills with attention to detail., • Excellent organizational and time-management abilities., • Strong verbal and written communication skills.Ability to work both independently and collaboratively in a fast-paced environment.

Job DescriptionCompany Description CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. Job Description We are seeking a skilled and experienced Process Engineer III/ IV with deep expertise in small molecule manufacturing to join our engineering consulting team. This role combines technical leadership with strategic client engagement, supporting process design, scale-up, optimization, and regulatory compliance across a variety of pharmaceutical and chemical industry projects. The Process Engineer III will lead the design and execution of process scopes—such as unit operations, systems, or facility areas—on small to medium-sized projects. You will manage scope, budget, and schedule, while maintaining clear communication with clients and internal teams. This role also includes mentoring junior staff, contributing to high-quality deliverables, and supporting capital project planning and regulatory alignment. This position can be based near any CRB location Key Responsibilities • Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization., • Conduct site assessments, gap analyses, and provide recommendations for process improvements and compliance., • Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and mass/energy balances., • Translate client requirements into actionable design scope and document decisions, open issues, and action items., • Identify and escalate scope changes or design deviations to project leadership., • Collaborate with cross-functional teams including architecture, mechanical, electrical, and construction., • Prepare technical reports, proposals, and presentations for internal and client stakeholders., • Support capital project planning including feasibility studies, equipment selection, and facility design., • Ensure alignment with industry standards including cGMP, FDA, EMA, and ICH guidelines., • Participate in advanced project activities such as:, • Technical bid tabulations, • Vendor package management, • Factory acceptance testing, • Risk assessments (e.g., HAZOP, HACCP), • 3D model reviews and coordination, • Sequence of operations and functional specification reviews, • Mentor junior engineers and design staff., • Lead system design programming and planning with support from senior engineers., • Participate in cross-discipline squad checks and drive overall project quality.Qualifications Minimum Qualifications • Bachelor’s or Master’s degree in Chemical Engineering or a related discipline (ABET-accredited)., • Minimum of 5 years of experience in small molecule process engineering, preferably in a consulting or client-facing role., • Strong understanding of chemical synthesis, purification, and formulation processes., • Experience in design firm or operating company settings within a related industry., • Strong written and verbal communication skills., • Intermediate experience with applicable industry and regulatory guidance and building codes., • Advanced technical knowledge and experience with small molecule API manufacturing equipment and utility systems, such as chemical reactors, filters, centrifuges, dryers, vacuum pumps, scrubbers, purified water, process compressed gases, and engineered heat transfer fluid systems., • Experience designing and implementing engineering controls for containment of highly potent APIs., • EIT or PE certification., • Experience coordinating and managing design within project teams and with external partners., • Familiarity with commissioning, startup, qualification, and troubleshooting of process systems., • Experience with regulatory environments and validation documentation., • Prior experience in engineering consulting or client services., • Familiarity with process safety, risk assessments, and HAZOP studies. Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Job Description About Us: Infusion For Health is a rapidly expanding private-equity-backed healthcare provider specializing in infusion therapies for chronic conditions. We are dedicated to improving the lives of our patients through exceptional care and innovative treatments. As we continue to grow throughout California and beyond, we are seeking talented and motivated sales professionals to join our team. Position Overview: We are seeking a highly motivated and dynamic Infusion Sales Representative to drive growth for our infusion centers in the San Diego, CA regions. As an Outside Sales Rep, you will be responsible for managing provider relationships and generating referrals from physicians, particularly in oncology, hematology, gastroenterology, and rheumatology. This home-based role involves up to 60% travel within the territory to build strong relationships and expand business opportunities. Compensation: * Base Salary: $85,000 – $120,000 * Incentive Compensation: Uncapped monthly bonuses with top performers earning $100,000+ in additional annual incentive compensation Key Responsibilities: • Develop, implement, and report on sales strategies and goals, ensuring key performance metrics are met and exceeded., • Achieve and exceed sales quotas, driving revenue growth for the company., • Cultivate and maintain relationships with high-volume physician practices, particularly those specializing in oncology, hematology, gastroenterology, and rheumatology., • Educate physicians and their teams on Infusion For Health’s services, fostering trust and encouraging referrals., • Identify key target providers, create engagement strategies, and work to increase referral volume., • Monitor provider performance and collaborate to implement tactics that drive higher referral rates., • Work alongside pharmaceutical reps, health plans, and local health systems to enhance service delivery and further expand the business., • Proven experience in sales, with a strong track record in developing physician relationships and driving referrals in oncology, hematology, gastroenterology, and/or rheumatology, specifically in infusions., • A minimum of 3-5 years of sales experience, preferably in healthcare, health services, or medical sales., • Strong presentation and communication skills, with the ability to engage effectively with physicians, office staff, and other key stakeholders., • Bachelor’s degree in business, healthcare, or a related field., • Strong analytical, organizational, and problem-solving skills to manage territories and track sales performance., • Be part of a pioneering healthcare company making a significant impact on patients' lives., • Work with a dynamic, supportive team that values your sales expertise and contributions. At Infusion for Health, we are committed to equitable pay for all employees, and we strive to be transparent with our pay practices. The estimated base salary for this position is $85,000 to $120,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position is also eligible for uncapped monthly incentives.

Job Description Genomic Life is seeking a motivated Regional Sales Director to join our growing team! The Regional Sales Director (RSD) is a highly entrepreneurial and motivated individual contributor with experience in healthcare markets and proven ability to sell sophisticated healthcare products to both sophisticated and generalist buyers. This individual is responsible for driving revenue and membership growth exclusively through new logo sales. As the market facing leader within their respective geography, this person will be expected to generate corporate and broker interest and work diligently to close qualified leads. Each RSD will work closely with company management to help create and deliver on revenue goals. This person will be a team player sometimes sharing accounts across regions where shared relationships exist within the broker/client community. Achieving profitable revenue growth while maintaining a deep passion for the new world of genomic medicine and an urgent desire to improve health through genetics-based prevention are expected. Job Type: Full time Salary Range: $110-155k plus commission Preferred Region: Northeast or Midwest Responsibilities: • Work with a passionate entrepreneurial team to meet or exceed sales goals on a multi-year basis, • Communicate the company's value propositions through entrepreneurial efforts and the use of a variety of technology tools as well as traditional channels including presentations and proposals, conference participation, and other networking opportunities, • Leverage internal subject matter expertise, medical directors and clinical resources in a manner that elevates close ratios for complex, large sales, • Maintain technical and professional knowledge by attending internal sales meetings and instructional meetings, reviewing professional publications, participating in professional organizations, and growing personal networks, • Document customer interactions and maintain data related to activities, opportunities and distribution partners within Salesforce with a willingness to adopt new technology in the changing world of AI based applications for sales., • Develop and review sales pipeline strategies and create and execute on strategic selling plans for key pursuits, • Multiple years of experience as a high performing sales representative in the healthcare field, • Bachelor's degree or higher and the ability to communicate our science broadly to anyone from C-suite to HR benefits generalists, • Ability to read, learn, understand and communicate broadly on the benefits of genetic testing and genomic medicine, • Ability to work well within a team concept that encourages sales reps to engage, communicate and share success in order to achieve company goals, • Background of selling diagnostic or pharmaceutical products in the healthcare space and the confidence to cross fields to develop strong broker relationships in the employer benefits space, • Curious mind and strategic thinker with proficiency in problem solving and critical business measurements, including ROI, Breakeven, and other quantitative measures used by consultants and clients to make data-driven decisions, • Ability to travel 40% of the time, • Presentation and public speaking skills About Genomic Life: Genomic Life's mission is to be the best in the world at navigating individuals to the genomics that matter. We provide clinically relevant proactive genetic testing all in one program, making it easy to prevent, diagnose, and treat disease. Our nationwide team is driven to make a difference for the members, clients, and patients we serve. We are bringing the science of today to the medicine of tomorrow. We are passionate about what we do and the extraordinary transformation that genomics will have on healthcare.

Job DescriptionCompany 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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description As a Senior Field Engineer you will conduct on-site Field Evaluations of electrical equipment for compliance to regulatory product safety standards (UL, NFPA, CSA, ANSI, etc.). Perform construction and engineering review of electrical equipment in a multitude of industries (manufacturing, laboratory, medical, commercial, retail, food service, etc.). 100% travel both domestic and internationally, though majority of travel will be within the lower 48 (must possess or be able to obtain a passport). Territory: San Francisco, CA; Los Angeles, CA; Las Vegas, NV; Phoenix, AZ. RESPONSIBILITIES The Senior Field Engineers’ duties and responsibilities include, but are not limited to: • Perform Field Evaluations under the Eurofins E&E North America/MET Labs Field Labeling program, • Review scope of work and identify all necessary items prior to arranging travel, • Responsible for coordinating all travel arrangements, • Communicate with client, AHJ, contractors, and other relevant parties, • Identify applicability of national codes and standards, • Review manuals, schematics, BOMs, site procedures, data sheets and more, • Document construction details and any non-conformances during the inspection, • Assess compliance to the relevant UL, NFPA, CSA, or ANSI standards, • Determine eligibility of equipment for labeling and issue all final reports, • Submit all expenses and necessary documentation for billing, • Meet or exceed minimum billing goals while meeting project deadlines, • Grow relationships with clients and promote our company and the various services we offerQualifications The ideal candidate will demonstrate the following experience, skills, and personal attributes: • Electrical Engineering Bachelor’s Degree preferred and/or equivalent experience., • MUST have direct Field Engineering experience with a Nationally Recognized Testing Laboratory (NRTL) or Field Evaluation Body (FEB) using product safety standards., • Experience as a Follow-Up Inspector is not relevant unless there is experience performing multiple UL 508A training seminars., • Conversant with UL 508A, UL 61010-1, UL 73, NFPA 70, & NFPA 79., • Though not required, experience with Hazardous Location and CSA standards is desired., • Must have strong technical writing skills and experience with Microsoft Office Suite., • This position requires strong verbal and written communication skills and excellent interpersonal skills as the candidate will interact with customers on many different levels., • Must be able to work in elevated and/or confined spaces. Must be able to lift 30+ pounds., • This position requires a strong electrical background and understanding of electrical systems., • Must possess sound problem-solving skills., • Skillful ability to work independently., • Position is entirely remote. Must be near a major airport. Additional Information Salary Range: • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: We are looking for an Automation Engineer who provides administrative and technical oversight of Building Automation Systems (BAS) in a GMP-regulated environment, with a primary focus on documentation, change coordination, system monitoring, and compliance support rather than hands-on programming. Acts as a liaison between Facilities, Quality, IT, and external vendors to ensure BAS systems remain compliant, reliable, and inspection-ready. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) • Updating and maintaining BAS/BMS documentation, including SOPs, design documents, and lifecycle deliverables such as DSs, FSs, CAs, RTMs, and RAs., • Authoring and executing validation documentation, including BMS IOQs, engineering tests, protocols, and final reports., • Owning and managing BAS-related change records, ensuring proper documentation, impact assessment, and GMP compliance., • Coordinating and overseeing routine BAS work-order maintenance activities., • Reviewing BAS data, including OOS point investigations, user access reviews, and quarterly alarm reviews., • Supporting cross-functional communication between Facilities, Quality, IT, and vendors to maintain system reliability and audit readiness. Education: • Experience working with BMS/EMS platforms, especially Siemens Desigo., • Background in GMP documentation, validation, and CSV/SDLC processes., • Familiarity with BAS operations in biotech or pharmaceutical environments., • Understanding of BAS/BMS system structure, alarm logic, and point configuration review., • Skilled in writing, reviewing, and managing controlled documents and validation protocols., • Strong communication, organization, and cross-functional coordination abilities., • Ability to manage multiple priorities in a fast-paced, compliance-driven environment. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $97,000 to $110,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

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

Job DescriptionSales Executive – Freight Forwarding Purpose of Role Drive profitable new business through consultative, solutions-based selling across a full suite of global logistics and supply chain services. Maintain integrity, accuracy, and transparency in all revenue reporting and client discussions. Why This Is a Great Place to Work • Privately held, financially strong, and growing nationwide, • Highly respected reputation for ethics, service quality, and operational reliability, • True entrepreneurial culture — sales reps are empowered, not micromanaged, • Fast decision-making from leadership (no bureaucracy), • Best-in-class operations teams that make it easier to onboard and retain accounts, • Industry-leading technology: real-time tracking, API/EDI integrations, advanced WMS, • Strong support from regional EVP-level sales leaders, • Competitive compensation structure tied to performance, • Long-term career stability with national and international expansion plans What You Will Sell Core Freight Forwarding Services • International & domestic air freight, • International & domestic ocean freight, • FTL, LTL, cross-dock, distribution, • Bonded and FTZ services, • Storage, inventory management, • Pick/pack/ship, kitting, labeling, • E-commerce fulfillment with advanced WMS (Extensiv), • Expedited/time-definite (NFO, charter, critical shipments), • White-glove and high-value handling, • Project cargo: heavy-lift, OOG, crating, rigging, • Automotive, • AI / High-tech, • Pharmaceutical, • Aerospace, • Government / DOD, • Medical devices, • Retail / cosmetics, • Shipment management platform with real-time visibility, • Full API/EDI integration for automation, • Atlanta, • Dallas, • Houston, • Chicago, • Los Angeles, • San Diego, • San Francisco, • San Jose Requirements Core RequirementsRemote Sales Requirements • Remote roles require $2M+ annual GP Professional Standards • Demonstrates integrity, commitment, and passion, • Must be currently employed in a logistics sales role, • No non-compete preferred, • Strong verbal and written communication skills, • Proficient with Excel, PowerPoint, and Word Sales CapabilitiesConsultative Selling • Ability to diagnose customer needs and design customized logistics solutions, • Comfortable discussing automation, EDI/API integration, and operational efficiencies, • Proven history of building loyal, portable client relationships, • Can articulate monthly revenue, GP, margins, and industry mix without embellishment, • Clear prospecting strategy (cold calling, cadence, vertical targeting), • Skilled in CRM execution and organized follow-up, • Strong discipline in pipeline management and forecasting Experience Requirements • Minimum 5+ years of successful freight forwarding sales experience, • Ability to demonstrate true account portability and retention, • Must be accurate — no inflated performance claims Benefits • Medical, dental, and vision insurance, • 401(k) with company match, • Life, short-term, and long-term disability coverage, • Paid vacation, sick time, and holidays, • Flexible/remote options for high-performing sales reps, • Competitive base salary + strong commission structure, • Annual performance bonuses, • Company laptop and mobile reimbursement, • Ongoing sales, compliance, and technology training, • Supportive, fast-moving culture with strong operations backing

Job Description COMPANY DESCRIPTION: Syner-G is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market. We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality. Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) • Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification., • Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR)., • Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures., • Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities., • Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments., • Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes., • Support the resolution of regulatory observations or manufacturing site issues. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education: • 4-7 years of experience within the biotech, pharmaceutical, or medical device industry., • Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required., • Validation expertise in Equipment, CSV, Method, and Process., • Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job Description Job Description Do you love digging into the design, manufacture and science of your cases and building a technical defense? Are you ready to take on more responsibility in your cases and ready for a real challenge? Are you getting the hands-on litigation experience you crave in your practice? Work with a national law firm that values you for your contributions! Bowman and Brooke LLP is a nationally recognized litigation firm focused on defending high-stakes product liability and complex litigation matters. With over 200 attorneys across 17 offices nationwide, we are known for our deep bench of trial lawyers and a proven track record of successfully defending Global 500 and internationally based companies, in high-exposure and technically intricate lawsuits in multiple jurisdictions. Our practice spans a wide range of industries, including automotive, pharmaceutical, consumer products, and medical devices. We are courtroom-driven, client-focused, and committed to legal excellence. Bowman and Brooke has earned top national rankings from Chambers USA, The Legal 500 and Law360, and has been repeatedly recognized as a leader in product liability defense. We foster a collaborative and inclusive environment that encourages professional development, mentorship, and hands-on trial experience. In 2025, the firm hit the major milestone of surpassing 1,000 trials. What you will do - We are seeking a motivated and talented Associate or Counsel to join our Toxic Tort Liability Practice Group in our California offices. This position offers a dynamic opportunity for attorneys with hands-on experience in litigation to grow their careers in a supportive and fast-paced environment. You’ll be a vital member of our team, with hands-on responsibility for day-to-day case development—including handling depositions, engaging directly with clients, collaborating with technical experts, managing critical discovery tasks, and drafting and arguing motions. You’ll also play a key role in supporting partners on strategic litigation planning, all the way through trial preparation and execution. We’re looking for a self-starter with 3+ years of litigation experience, who is eager to develop expertise across a broad range of matters. The ideal candidate will possess strong research, writing, and advocacy skills, a high degree of independence and initiative, and a desire to contribute meaningfully to the success of our clients. At Bowman and Brooke, LLP, you will: • Work closely with experienced attorneys who are committed to your growth and mentorship., • Be given substantive responsibility from the start., • Collaborate across our offices to deliver personalized, strategic legal solutions., • Enjoy the benefits of a fast-paced, high-volume practice with the support of a dedicated team. This is a hybrid position, with flexibility to work remotely. If you're ready to take the next step in your legal career in a dynamic and supportive environment—we’d love to hear from you! Basic Qualifications - • JD or foreign equivalent from accredited law school, • Activate member of the California Bar, • 3+ years of litigation experience Preferred Qualifications – • Understanding of current state and federal procedures, • Excellent written and oral communication skills, • Attention to detail and commitment to excellence, • Trial experience preferred, but not required Benefits: We offer a competitive compensation and benefits package including everything you’d expect -- medical, dental, and vision insurance; firm paid life insurance and short and long-term disability; retirement savings plan with employer profit sharing contributions, paid parental leave, bonus programs and more. Our office is passionate about our clients and each other, seeking opportunities for achieving a high level of success while also having fun. We also offer a variety of mentorship and growth opportunities along your path to partnership. This position is hybrid and offers work from home and in-office workdays. Visit us on the web to learn more about our firm:

Job Description Exciting Opportunity for a Warranty Defense Associate Attorney – Join Our California Team! Work with a national law firm that values you for your contributions! Bowman and Brooke LLP is a nationally recognized litigation firm focused on defending high-stakes product liability and complex litigation matters. With over 200 attorneys across 17 offices nationwide, we are known for our deep bench of trial lawyers and a proven track record of successfully defending Global 500 and internationally based companies, in high-exposure and technically intricate lawsuits in multiple jurisdictions. Our practice spans a wide range of industries, including automotive, pharmaceutical, consumer products, and medical devices. We are courtroom-driven, client-focused, and committed to legal excellence. Bowman and Brooke has earned top national rankings from Chambers USA, The Legal 500 and Law360, and has been repeatedly recognized as a leader in product liability defense. We foster a collaborative and inclusive environment that encourages professional development, mentorship, and hands-on trial experience. In 2025, the firm hit the major milestone of surpassing 1,000 trials. What you will do - We have an opportunity for an Associate Litigation Attorney with litigation experience who is interested in joining our Warranty Defense team in our San Jose, Costa Mesa, San Diego or Torrance, CA locations! You’ll be a vital member of our team, with hands-on responsibility for day-to-day case development—including handling depositions, engaging directly with clients, collaborating with technical experts, managing critical discovery tasks, writing and arguing motions, managing critical discovery tasks, and working with partners through trial. You’ll also play a key role in supporting partners on strategic litigation planning, all the way through trial preparation and execution. This is a hybrid position, with flexibility to work remotely. If you're ready to take the next step in your legal career in a dynamic and supportive environment—we’d love to hear from you! Who you are – Basic Qualifications: • JD from accredited law school, • Active California Bar admission, • Experience in warranty defense preferred, • Understanding of current state and federal procedures, • Excellent written and oral communication skills, • Attention to detail and commitment to excellence, • Ability to multitask in a fast-paced environment, • Strong organizational, time management, and project management skills Salary for this position is $170,000 - $200,000+ depending on experience. Visit us on the web to learn more about our firm:

Job DescriptionCompany Description EVERSANA INTOUCH™ is a leading full-service, global healthcare agency serving the life sciences and pharmaceutical industries. We provide next-generation creative and media services, enterprise solutions and data analytics services for clients. We combine the power of world-class creative and digital teams with deep market access, payer, and healthcare communications expertise to provide innovative solutions to life science companies that want to connect with consumers, healthcare professionals, and payers. We get fired up when people talk about getting—and staying—healthy. That’s where we find our inspiration: in the very human experiences of patients, doctors, and even each other. Then, we collaborate on ways to make caring for one’s health more achievable, connecting patients and physicians with the information and tools they need. And as a part of EVERSANA, a pioneer in next-generation commercial services, we connect dots that other agencies can’t, helping drive commercialization success. Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA INTOUCH, our people, clients and most importantly, the patients we serve. Job Description The Senior Director, Analytics is a trusted internal strategic analytic partner managing a brand or portfolio team to deliver client delight and growth. This is a leadership role within our Marketing Analytics group. The Senior Director, Analytics works with clients, subject matter experts (SMEs) in other departments, and our Marketing Intelligence colleagues to deliver insights that inform strategy development and drive the optimization of our Omnichannel programs. Responsibilities include managing direct reports, proposing ideas, managing senior client relationships, delivering presentations, and contributing to the development of our Analytics practice. The Senior Director, Analytics must be a strong leader skilled in leveraging data-driven solutions to inform and drive Omnichannel program performance. The ideal candidate provides insights from campaigns, claims, and internal client data that can inform strategies and deliver quantified impact. The role involves leading a portfolio of client engagements, providing guidance to managers and analysts within the team, and ensuring effective measurement planning and performance analysis. The role also involves advocating for the implementation of optimization recommendations, serving as a consultative partner to clients and SME colleagues, and identifying growth opportunities to help clients address challenges. The candidate will be responsible for growing existing client relationships and supporting new business development opportunities. Success in this role is measured through client satisfaction, internal team/stakeholder satisfaction, and team billability. Qualifications ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: * Serve as lead partner and contact for Analytics on portfolio/brand engagement for team and clients * Design and lead presentations and communicate business value derived from each engagement to senior clients. * Provide oversight for data analysis and interpretation of results in business context, presenting findings and implications to key stakeholders at all levels * Understand the client’s business context and goals and how marketing activities are evaluated to support these goals. Collaborate with the client team and internal SMEs (Account Management, Planning, CX, CS, UX) to improve campaign performance and user experience. * Manage scoping and budgeting process for assigned portfolio and brands and maintain relationship with AM/PM to ensure up-to-date analytics scopes. Accountable for portfolio revenue & profit and secure scopes by developing analytics proposals including definition of deliverables, timing, costs. * Secure growth by providing thought leadership and direction. Participate in advocating for data-driven solutions through Accounts Management and Omnichannel teams. * Ensure deliverables are on time, accurate, and compelling to client/business objectives and manage internal teams’ and clients’ expectations regarding timelines * Manage projects responsibly, assigning analytics talents to appropriate tasks * Develop new methodologies and frameworks building on existing EVERSANA INTOUCH intellectual capital and partner with key external vendors and partners * Enhance data strategy and maintain expertise in omnichannel marketing, analytical tools, techniques, and similar requirements. * Coach and mentor talent, creating an environment for talent to grow, stay engaged, and perform their best * Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. * All other duties as assigned MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. * 12+ years of experience in an Analytics role * 3+ years in a Pharmaceutical Marketing Analytics role preferred. Agency experience a plus. * Compelling presentation, writing, and storytelling abilities * Advanced knowledge of omnichannel or multichannel marketing analytics with a focus on digital (e.g., Web, Email, Paid media, Social media, Organic search, Mobile apps) * Ability to manage 2 or more direct reports * Command of data analysis to justify insights or recommendations impacting a client’s brand and business goals * Proficiency with MS Office Suite * Strong analytical and problem-solving skills * Desire and ability to mentor and train employees and work collaboratively with team members * Strategic thinking to lead teams and mentor staff to achieve success across multiple accounts * Interest in self-education and staying updated on marketing analytics trends and tools * Self-directed and motivated with strengths in planning, organizing, and project management to meet deadlines, prioritization and multitasking skills * Master of written and oral communication skills * Able to set priorities for the team and manage timelines Additional Information OUR CULTURAL BELIEFS Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and hold myself accountable. Embrace Diversity I create an environment of awareness and respect. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful, and timely dialogue. Always Innovate I am bold and creative in everything I do Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

Job DescriptionDescription: About the Company As a life science company and a leading supplier to global research markets, we offer a comprehensive product portfolio along with outstanding hands-on customer service to ensure every laboratory has the tools and support they need. Our markets include pharmaceutical and biotechnology businesses, research institutions, hospitals, reference labs, and more. Be part of making a difference At Genesee, we believe we can help improve our communities and transform the world through science. Our shared desire to make a difference is what drives and inspires us. We are a fast-growing, dynamic team that listens to each other and embraces collaboration. We foster an open, friendly work environment and show up for one another every day. Role: Sr. Sales Development Representative (SDR) Reports to: Regional Director of Sales FLSA: Non-Exempt Location: El Cajon, CA Why is this role important at Genesee Scientific? The Sr. Sales Development Representative (SDR) plays a critical role in developing and expanding relationships with existing customers and re-engaging inactive accounts. This role focuses on account growth, retention, and long-term customer success, working closely with Account Managers and Sales Leadership to drive sustained revenue. What will you do: • Own and manage an assigned book of existing and inactive customer accounts, • Proactively engage customers to understand purchasing behavior, challenges, and future needs, • Re-engage dormant accounts and identify opportunities to restore and grow spend, • Educate customers on Genesee’s products, services, promotions, and value proposition, • Drive incremental revenue by engaging in discovery conversations and gaining customer commitment to participate in a future meeting with their Account Manager, • Use Salesforce and sales tools to track customer interactions, pipeline, and opportunities, • Collaborate with Customer Service and Marketing to deliver a seamless customer experience, • Bachelor’s degree in business, science, or equivalent experience, • 1–3 years of experience in sales, account support, customer development, or customer-facing roles, • Strong communication skills with the ability to build and maintain customer relationships, • Proven ability to manage multiple accounts and priorities, • Results orientated, strong work ethic and an ability to excel within a rapidly changing and growing organization, • Proficient in Microsoft Office Suite applications; experience with CRM/Salesforce is a plus, • Enjoy owning relationships and driving account growth, • Are proactive, organized, and comfortable managing a book of business, • Can navigate customer conversations and objections, • Are curious, analytical, and solution-oriented, • Are comfortable using technology and data to guide decisions Perform the following tasks, with or without reasonable accommodation: • Primarily sedentary work on a computer in a climate-controlled office environment, • Regularly sit for extended periods, with occasional standing, walking, and lifting of up to 25 pounds, • Training and professional growth initiatives, including comprehensive onboarding programs for new team members, • We provide financial well-being with competitive compensation packages and 401 (k) retirement savings plans, • Health care and well-being programs including medical, dental, vision, life, short- and long-term disability and employee assistance programs Employment offers are subject to successful completion of a background check and pre-employment drug test. Genesee Scientific is proud to be an Equal Employment Opportunity employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. Requirements:

Job Description Job Summary: The Regional Marketing Manager will develop, execute, and monitor local marketing strategies across the US region, focusing on event marketing to optimize activities and increase brand awareness. This role involves managing offline events throughout their full lifecycle and requires collaboration with multiple stakeholders to effectively represent the company’s identity and presence within the life science community. Occasional night and weekend work may be required to support on-site events and internal teams. Key Responsibilities: • Develop local marketing plans to maximize event ROI and raise brand visibility., • Design and implement both offline and online event strategies tailored to regional markets., • Collaborate with internal teams to develop localized promotional campaigns considering regional regulations and cultural nuances., • Partner with digital marketing to promote events via social media, webinars, and newsletters, and analyze engagement metrics to optimize strategies., • Manage logistics for trade shows and events, coordinating vendors and carriers to ensure smooth execution., • Prepare detailed reports and presentations to communicate insights and recommendations to stakeholders., • Conduct market research on customer behavior through surveys, interviews, and focus groups to improve marketing initiatives., • Monitor competitor activities and market trends to inform strategic planning., • Supervise and mentor the offline event marketing team to foster collaboration and performance., • Manage relationships with distributors, collaborators, and partners across the US., • Travel up to 30-40% depending on event schedules. Minimum Qualifications: • Master’s degree in life science or a related discipline., • Minimum 3 years of marketing experience, preferably in biotechnology, pharmaceutical, or healthcare sectors. Preferred Qualifications: • An advanced degree or an MBA is preferred., • 5+ years of B2B or B2C marketing experience within the biotech or pharmaceutical industry., • Fluency in English and Mandarin Chinese preferred. Skills & Abilities: • Passion for the life sciences and pharmaceutical industry with alignment to company values., • Excellent written, verbal communication, and presentation skills., • Proficient in marketing tools such as Salesforce, Adobe, Canva, Constant Contact, and Microsoft Office (especially Excel and PowerPoint)., • Strong leadership capabilities with resilience under stress and an innovative mindset., • Analytical, critical thinking, and problem-solving skills., • Ability to create strategic vision and execute plans effectively., • Strong multitasking and time management skills with the ability to meet deadlines., • Project management experience, coordinating multiple global stakeholders., • Willingness to travel frequently for marketing events across the US. Work Location: San Diego, CA or San Jose, CA (Hybrid) Work Environment & Physical Demands: This role primarily operates in an office environment, with occasional exposure to laboratory and warehouse settings. Physical requirements include regular use of hands and fingers to operate objects and controls, frequent standing, talking, and hearing.

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 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 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. Position: Business Development Director Location: San Diego, California Position Type: 5 days Onsite Exempt Position Salary range: $100,000-$200,000 annually. Job Summary: We are seeking an experienced and strategic Business Development Director to drive growth, partnerships, and revenue expansion within the biotechnology industry. This role is responsible for identifying new business opportunities, cultivating relationships with key stakeholders, and leading strategic initiatives to enhance market presence. The ideal candidate will have a strong background in biotech, life sciences, or pharmaceuticals, along with expertise in strategic partnerships, licensing, and market expansion. Key Responsibilities: • Develop and execute a comprehensive business development strategy to drive revenue growth and market expansion., • Identify and evaluate new partnerships, licensing opportunities, and collaborations with biotech firms, pharmaceutical companies, and research institutions., • Lead initiatives to expand product pipelines, service offerings, and commercialization strategies., • Establish and maintain strong relationships with key industry stakeholders, including investors, corporate partners, and regulatory bodies., • Negotiate and close strategic partnerships, joint ventures, and licensing agreements to support business goals., • Represent the company at conferences, networking events, and industry forums to enhance brand visibility and drive engagement., • Conduct market research and competitive analysis to identify trends, emerging opportunities, and potential risks., • Provide strategic insights and recommendations to senior leadership for business expansion initiatives., • Monitor industry regulations, funding opportunities, and government policies impacting the biotech sector., • Work closely with R&D, finance, marketing, and regulatory teams to align business objectives with scientific advancements., • Support the development of commercialization strategies for biotech products and innovations., • Lead and mentor a team of business development professionals to achieve company goals. Requirements • 10 year work experience;, • More than 5 years team management experience., • Manage team subordinates more than 21., • The average job tenure is 30 months., • Life-science industry, IVD preferred., • Less 7 companies, no consulting experience., • Regulatory Understanding, Familiarity with FDA, IVDR, and other relevant regulations affecting biotech and diagnostics., • Market Analysis, Ability to assess market trends, competition, and business opportunities. Benefits • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

Job DescriptionSalary: $150,000 - $200,000/year + bonus As a subject matter expert, this role will support the execution and delivery of clinical and translational biomarker services for Sponsor and internal R&D studies. This role will function to lead and support immunostaining assay development, biomarker projects, and advanced image analysis including developing and applying AI-driven image analysis algorithms to quantitatively assess histopathology and biomarker data, while also serving as a scientific partner to clients from study design through data interpretation and presentation. The role will work cross-functionally with pathologists, laboratory technicians, scientists, project operations and business development teams, and will directly support pharmaceutical and biotechnology clients in planning, executing, and interpreting biomarker studies across preclinical and clinical programs. What you'll be doing: Lead/Support Scientific Efforts for Computational and Digital Pathology • Act as a scientific interface with clients, participating in client meetings, protocol reviews and data review meetings, • Provide expert input on design and conduct of clinical or translational studies incorporating biomarker endpoints and omics and non-omics techniques including but not limited to immunostaining, proteomics, spatial biology, computational and digital pathology., • Prepare and/or support the preparation and review of project plans, analysis plans and study reports, abstracts, manuscripts, and technical reports., • Perform and/or support the analysis and interpretation of biomarker data including providing clear, scientifically rigorous data visualizations, analyses, and summaries. Assay Development, Image Analysis, and Algorithm Development • Partner with laboratory technicians to support immunostaining assay development, optimization, and validation., • Define analytical endpoints, scoring strategies, and quality control metrics aligned with assay performance., • Contribute to assay validation documentation and analytical reports as required., • Develop, validate, and maintain image analysis pipelines for immunostaining (IHC), immunofluorescence (IF), in situ hybridization (ISH), and multiplex assays., • Design and implement AI/machine learning algorithms for tissue segmentation, cell characterization, and biomarker quantification., • Collaborate with pathologists through end-to-end workflows including assay development, validation, quantitative read-outs and interpretation., • Ensure traceability, reproducibility, and documentation of analysis workflows. Business Development Support • Assist with business development activities including participating in client meetings, requests for proposal (RFP) responses, project pricing, protocol review, and bid defenses as needed., • Provide advice to sponsors seeking guidance, • Assist in the development of sales, marketing and promotional materials as needed. Product and Service Innovation Support • Contribute to continuous improvement of computational, digital pathology, spatial biology and translational research capabilities., • Assist in the development of our product/service platforms to ensure all stakeholder requirements are being considered, documented, and translated to the final solution., • Participate in brainstorming meetings and functionality reviews. Qualifications • Post-graduate degree / professional designation; 7-9 years related experience, plus continuous training and knowledge/skills upgrading, • Strong experience with digital pathology and image analysis, • Solid understanding of histopathology and immunostaining techniques, • Experience working in CRO, laboratory, biopharma and/or regulated research environment, ideally supporting clinical and translational research studies, • Experience presenting data to external stakeholders or at scientific meetings, • Scientific rigor and attention to detail - able to communicate complex scientific concepts and results clearly to all stakeholders, • Strong written and oral English communication skills, problem-solving and analytical thinking, • Ability to manage multiple projects in fast-paced environment with a collaborative mindset across disciplines Note: Compensation is dependent on the unique experience, skills, and education the successful candidate brings to the role. The range above represents an estimated base salary that we would expect to compensate at, but we encourage applicants to speak with the member of the TA team if contacted for an initial phone screen should your expectations differ from those listed above.

Job DescriptionAs a subject matter expert, this role will support the execution and delivery of clinical and translational biomarker services for Sponsor and internal R&D studies. This role will function to lead and support immunostaining assay development, biomarker projects, and advanced image analysis including developing and applying AI-driven image analysis algorithms to quantitatively assess histopathology and biomarker data, while also serving as a scientific partner to clients from study design through data interpretation and presentation. The role will work cross-functionally with pathologists, laboratory technicians, scientists, project operations and business development teams, and will directly support pharmaceutical and biotechnology clients in planning, executing, and interpreting biomarker studies across preclinical and clinical programs. Responsibilities • Act as a scientific interface with clients, participating in client meetings, protocol reviews and data review meetings, • Provide expert input on design and conduct of clinical or translational studies incorporating biomarker endpoints and “omics and non-omics” techniques including but not limited to immunostaining, proteomics, spatial biology, computational and digital pathology., • Prepare and/or support the preparation and review of project plans, analysis plans and study reports, abstracts, manuscripts, and technical reports., • Partner with laboratory technicians to support immunostaining assay development, optimization, and validation., • Define analytical endpoints, scoring strategies, and quality control metrics aligned with assay performance., • Contribute to assay validation documentation and analytical reports as required., • Develop, validate, and maintain image analysis pipelines for immunostaining (IHC), immunofluorescence (IF), in situ hybridization (ISH), and multiplex assays., • Design and implement AI/machine learning algorithms for tissue segmentation, cell characterization, and biomarker quantification., • Collaborate with pathologists through end-to-end workflows including assay development, validation, quantitative read-outs and interpretation., • Assist with business development activities including participating in client meetings, requests for proposal (RFP) responses, project pricing, protocol review, and bid defenses as needed., • Provide advice to sponsors seeking guidance, • Contribute to continuous improvement of computational, digital pathology, spatial biology and translational research capabilities., • Assist in the development of our product/service platforms to ensure all stakeholder requirements are being considered, documented, and translated to the final solution., • Participate in brainstorming meetings and functionality reviews.Qualifications, • Post-graduate degree / professional designation; 7-9 years related experience, plus continuous training and knowledge/skills upgrading, • Strong experience with digital pathology and image analysis, • Solid understanding of histopathology and immunostaining techniques, • Experience working in CRO, laboratory, biopharma and/or regulated research environment, ideally supporting clinical and translational research studies, • Experience presenting data to external stakeholders or at scientific meetings, • Scientific rigor and attention to detail - able to communicate complex scientific concepts and results clearly to all stakeholders, • Strong written and oral English communication skills, problem-solving and analytical thinking

Job DescriptionCompany Description Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description Due to growth Ergomed is recruiting for an experienced CRO Business Development Director. Duties and responsibilities • Initiates, coordinates and develops strategic plans and sales strategies within a specified territory or accounts., • Develop account strategies & implementation plans and expand through accounts, • Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts, • Collect critical information for proposal preparation and provide detailed input and leadership of the proposal process for each opportunity initiated, • Prepare and organize sponsor presentations, • Facilitate the preparedness of the team in attending any client meetings. For example, Capabilities meetings or Bid Defence Meetings (BDM), • Coordinate and monitor any budget or contract negotiations, post award of any work, within a specified territory or accounts., • Interact with operations, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations., • Establish and maintain regular contact and an excellent rapport with future and current clients., • Monitor and track competitor CRO activities, • Plan and attend major industrial events and tradeshows Qualifications, • Considerable CRO sales experience with strong negotiation and analytical skills, • An established network of decision makers within Pharmaceutical and Biotechnology companies and a proven track record of identifying and securing profitable service contracts., • Awareness of trends and government policies and regulations in the clinical trials area of Ergomed Group countries, • Excellent communication skills and team leadership capabilities consistent with influencing and driving multiple stakeholders towards meeting the customer’s needs., • Strong and effective presentation skills; ability to convincingly present features and benefits of service to clients, • Excellent organisational, planning and multitasking skills, as well as a predisposition to entrepreneurship, results and customer focus, • Ability to travel according to the needs of the business development strategy Additional Information We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: * Training and career development opportunities internally * Strong emphasis on personal and professional growth * Friendly, supportive working environment * Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application.

Job DescriptionCompany Description Derex Technologies Inc specializes in providing IT consulting, staffing solutions and software services. Globally headquartered in Harrison New Jersey since 1996 Derex delivers the highest quality technology professionals and an array of customized IT talent solutions designed to improve productivity and drive results to global clients throughout North America. With over two decades of unparalleled experience, Derex provides supports to its clientele, across such industries as Systems Integration, Banking and Finance, Telecommunications, Pharmaceutical and Life Sciences, Energy, Healthcare, Technology, Transportation, and local and federal Government agencies. Job Description Position: SAP aATP expert Location : San Diego, CA Remote 50% Travel.. initially remote Visa : USC , GC Seeking a strong SAP aATP expert with hands‑on experience across sales processes, supply planning, and Production Planning & Detailed Scheduling (PP/DS). Experience with SAP gATP is preferred. The candidate should be able to translate business requirements into aATP designs and drive end‑to‑end implementation in complex supply chain environments. Key Responsibilities: Lead design, configuration, and deployment of SAP aATP capabilities, including product availability check, allocation, backorder processing, and supply protection. Configure aATP to support order promising, prioritization, and substitution logic. Integrate aATP with planning and execution processes including PP/DS, MRP, and sales order management. Support cross-functional solution design, including integration with SAP S/4HANA, EWM, and IBP where applicable. Troubleshoot complex ATP and planning issues across sales, planning, and production areas. Provide guidance, best practices, and knowledge transfer to internal teams. Required Experience: Strong hands-on experience implementing SAP aATP in S/4HANA. Experience with supply planning concepts and integration to planning tools. Hands-on experience with PP/DS (detailed scheduling, pegging, dependent demand). Ability to work in cross-functional teams and communicate with business stakeholders. Regards, Manoj Derex Technologies INC Contact : 973-834-5005 Ext 206 Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Direct Counsel is seeking a Corporate Associate Attorney (Licensing) to join a leading Am Law 100 firm in its San Diego office. This is an outstanding opportunity for an associate attorney interested in sophisticated licensing, commercial contracting, and technology transactions within the life sciences, biotechnology, pharmaceutical, medical device, and software sectors. About the Role The Licensing & Technology Transactions team works closely with cutting-edge companies developing groundbreaking technologies and therapeutics. As a Corporate Associate Attorney, you will draft and negotiate complex commercial agreements, support strategic corporate transactions, and advise clients on intellectual property, regulatory considerations, and deal structures across all stages of the product and company lifecycle. This role offers substantial client contact, the ability to interact with scientists and business leaders, and meaningful responsibility on impactful transactions. What You’ll Do * Draft, review, and negotiate a broad range of commercial agreements, including: * Licensing, collaboration, development, and research agreements * Clinical trial, manufacturing, supply, and service agreements * Patent license agreements and IP assignments * Material transfer agreements, NDAs, and distribution agreements * Strategic alliance and commercialization arrangements * Advise clients on contract interpretation, risk assessment, and compliance issues * Conduct due diligence on IP assets and contractual obligations in corporate transactions * Review high-volume commercial documents such as confidentiality agreements and terms and conditions * Collaborate with scientists, executives, and cross-functional business teams to align legal strategies with operational and commercial goals * Stay current on regulatory and legal developments affecting life sciences and technology transactions What We’re Looking For * A highly skilled Associate Attorney with 3+ years of experience drafting and negotiating commercial contracts for life sciences or technology clients * Strong understanding of intellectual property issues, including patents, trademarks, trade secrets, and copyrights * Experience with software licensing, SaaS agreements, and technology transactions preferred * Familiarity with data privacy considerations and emerging issues involving AI * Excellent negotiation, communication, and problem-solving skills * Ability to manage competing priorities, meet deadlines, and maintain exceptional attention to detail * A collaborative mindset and professionalism when working with clients, colleagues, and cross-disciplinary teams Qualifications * JD or LLM from an ABA-accredited law school * Admission to practice in California (or eligibility to sit for/admit via reciprocity) * Background in biology, immunology, biochemistry, or a related scientific field strongly preferred * Experience supporting biotechnology, pharmaceutical, medical device, digital health, or related technology clients Compensation & Benefits The annualized salary range for this Associate Attorney position is $260,000 – $310,000, depending on experience and other permitted job-related factors. Attorneys are bonus-eligible and receive access to a comprehensive benefits package.

Job Description Job Description: The Principal Scientist, Toxicology will provide scientific and operational leadership for non-clinical toxicology activities supporting drug discovery and development programs. This role is responsible for the strategic design, execution, oversight, interpretation, and reporting of outsourced GLP and non-GLP toxicology and related nonclinical studies to support global regulatory submissions. Essential Responsibilities: Study Monitoring & Nonclinical Oversight • Serve as Study Monitor with responsibility for oversight of all phases of outsourced GLP and non-GLP studies, including study enabling activities, study setup, protocol development, on-site monitoring of study conduct at CRO sites, and review of data and reports., • Provide scientific guidance, feedback, and directives to Study Directors and non-clinical sub-team members, including coordination of:, • CMC/Formulation planning to support study requirements, including manufacture, release testing, and shipping, • Sample shipping and logistics in collaboration with Operations, • Study timeline development in partnership with Project Management, • Maintain GLP compliance for all aspects of GLP studies and ensure adherence to internal SOPs and regulatory expectations., • Archive final study reports and associated data in IQVIA in accordance with regulatory and company requirements., • Collaborate closely with multidisciplinary drug discovery and development teams including CMC, Clinical, Regulatory Affairs, Pharmacokinetics, Bioanalytical, and Project Management., • Interface with drug safety team leads and represent toxicology as the primary point of accountability for the design, execution, data interpretation, and reporting of in vivo toxicokinetic (TK), tolerability, and investigative studies., • Develop protocols, procedures, data templates, and report templates for non-GLP studies and ensure submission-ready study reports to support advancement of drug candidates., • Contribute to and/or author nonclinical sections of global regulatory filings, including Pharmacology, PK, and Toxicology sections for INDs, NDAs, Marketing Applications, and regulatory briefing documents., • Oversee and manage CRO performance, timelines, budgets, and deliverables to ensure high-quality outcomes., • Contribute to budget estimates for nonclinical studies and ensure actual costs remain aligned with projected budgets on a quarterly and annual basis. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • PhD in Toxicology, Pharmacology, or a related life science discipline (DVM or equivalent may be considered), • 8+ years of relevant experience in pharmaceutical or biotechnology drug development, with demonstrated leadership in nonclinical toxicology, • Extensive experience overseeing outsourced GLP and non-GLP toxicology studies, • Direct experience supporting IND and later-stage regulatory submissions, • Strong knowledge of global nonclinical regulatory requirements (FDA, EMA, ICH), • Proven ability to lead cross-functional teams and manage external vendors, • Excellent scientific writing, communication, and presentation skills, • Must be able to work independently as well in cross-functional team settings with supervision as needed., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description 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. Position: Senior BD Manager Location: Onsite - San Diego, CA Position Type: 5 days Onsite Exempt Position Job Summary: We are seeking a results-oriented Senior Business Development Manager to support CorDx’s growth initiatives by identifying new business opportunities, managing strategic partnerships, and contributing to revenue expansion within the diagnostic sector. This role will focus on market research, relationship management, and deal execution in alignment with corporate strategy. The ideal candidate will have strong experience in business development or commercial operations within the biotechnology, medical device, or pharmaceutical industries. Key Responsibilities: • Market Development & Opportunity Identification, • Identify and evaluate new business opportunities, market segments, and potential partners aligned with company objectives., • Support market entry strategies and product launch initiatives through competitive and market analysis., • Assist in developing pricing and go-to-market strategies to support new product and market growth., • Partnership Management & Deal Execution, • Manage and grow relationships with key customers, distributors, and industry partners., • Support contract negotiations, licensing discussions, and partnership agreements., • Ensure smooth execution of partnership deliverables and monitor ongoing performance., • Sales Enablement & Commercial Support, • Collaborate with Sales, Marketing, and Product teams to align business development initiatives with commercial goals., • Provide market insights and customer feedback to guide product development and marketing strategies., • Track and report on business development KPIs, deal pipeline, and revenue opportunities., • Cross-Functional Collaboration, • Work with internal stakeholders in Regulatory, Finance, and Operations to support deal execution and partnership management., • Assist in coordinating participation in industry conferences, expos, and networking events to increase market presence., • Operational & Risk Management, • Analyze financial and operational data to support business proposals and partnership opportunities., • Required Qualifications:, • Bachelor’s degree in Life Sciences, Biotechnology, Business Administration, or a related field. An MBA is preferred., • 5–8 years of business development, sales, or strategic partnerships experience within the biotech, diagnostics, or life sciences industry., • Demonstrated ability to manage business relationships, negotiate agreements, and support revenue-driving initiatives., • Strong communication, interpersonal, and organizational skills., • Solid understanding of market trends, competitive analysis, and commercial operations within a regulated industry., • Preferred Qualifications:, • Experience in distributor management, or international business partnerships., • Familiarity with regulatory frameworks (FDA, ISO 13485) and intellectual property considerations in the biotech space., • Strong analytical skills with the ability to interpret financial models and market data., • 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 Job Description: We are seeking a highly motivated and qualified leader to join our Biostatistics Department as a Senior Biostatistician and work as a team lead to drive success. The Senior Biostatistician will provide strategic and hands-on statistical leadership to support the discovery, development, and clinical advancement of RNA-based therapeutics. This role partners closely with cross-functional teams to design, analyze, and interpret complex data across preclinical and clinical programs, ensuring scientific rigor and regulatory compliance throughout the drug development lifecycle. Key Responsibilities • Lead statistical strategy, study design, and data analysis for RNA-based programs across discovery, preclinical, and/or clinical development., • Develop statistical analysis plans (SAPs), protocols, and supporting documentation in alignment with regulatory expectations., • Provide statistical expertise for dose-finding, PK/PD modeling, biomarker analysis, and translational studies., • Collaborate cross-functionally with Clinical Development, Biometrics, Bioinformatics, Regulatory, and Discovery teams., • Oversee and review statistical outputs from CROs and external partners, ensuring quality and adherence to timelines., • Perform and interpret advanced statistical analyses using appropriate methodologies for high-dimensional and longitudinal data., • Contribute to regulatory submissions, investigator brochures, clinical study reports, and scientific publications., • Communicate statistical results clearly to both technical and non-technical stakeholders. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Remote work is on a case-by-case basis. Qualifications • PhD or MS in Biostatistics, Statistics, Mathematics, or a related quantitative field., • 5+ years of biostatistics experience in the pharmaceutical or biotechnology industry., • Direct experience supporting RNA-based therapeutics (e.g., siRNA, mRNA, antisense oligonucleotides)., • Strong understanding of drug development processes, including preclinical and clinical trial design., • Proficiency in statistical programming and analysis tools (e.g., SAS, R)., • Experience working with CROs and managing outsourced statistical activities., • Knowledge of regulatory guidelines (ICH, FDA, EMA) and submission requirements., • Experience with early-phase clinical trials and translational medicine., • Familiarity with bioinformatics or omics-related data analysis., • Prior involvement in regulatory interactions or submissions., • Must be able to work independently with supervision as needed., • Must be collaborative, work well with other team members in a matrix team environment., • Strong organizational skills with attention to detail and accuracy., • Ability to maintain a high level of confidentiality and exercise discretion., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job 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 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 Post-Marketing Product Quality Compliance Manager will oversee post-market product quality activities in compliance with FDA regulations and internal Quality System requirements. This role leads and develops a team responsible for product quality complaints, post-distribution quality monitoring, and the execution of quality-driven field actions, including recalls and market withdrawals. The manager provides strategic direction, coaching, and performance management to ensure timely, compliant, and effective execution of post-market quality processes while fostering a culture of quality and continuous improvement.Responsibilities * Post-Market Surveillance & Data Analysis • Manage the end-to-end product quality complaint process from intake through closure., • Assess complaints for product quality impact, GMP compliance risk, and field action triggers., • Trend and analyze post-market quality data to identify recurring or systemic issues., • Provide Quality oversight of vendors supporting complaint intake or triage., • Ensure accurate, complete, and timely complaint documentation., • Perform initial Quality assessments and ensure appropriate complaint classification., • Escalate potential adverse events to Pharmacovigilance per established procedures., • Escalate critical or high-risk quality issues in a timely manner., • Identify and assess potential recalls, market withdrawals, or corrections., • Lead quality-driven recalls, including regulatory notifications, documentation, and effectiveness checks., • Drive CAPAs resulting from post-market quality issues and verify effectiveness., • Maintain and improve SOPs related to complaints, post-market monitoring, recalls, and vendor oversight., • Oversee Internal Audit program and Inspection Readiness., • Act as a Quality SME during FDA inspections and audits., • Support preparation of inspection responses and supporting documentation related to post-market quality activities.Requirements, • Education: Bachelor’s degree in Life Sciences, Engineering, or a related field (Master’s preferred)., • Professional Experience: Minimum 7 years of experience in Quality within a regulated pharmaceutical, biologics, or cell therapy environment., • Leadership: 2 years of people management experience., • SME Knowledge: Hands-on experience with product complaints, post-market quality surveillance, and recalls or field actions., • External Oversight: Experience overseeing external vendors in a regulated Quality environment., • Regulatory Foundation: Strong knowledge of FDA Quality System and post-market requirements. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Description This team administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators. The Clinical Trials Regulatory Coordinator is responsible for: • Development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center., • Preparation of clinical trial protocols and related regulatory documents for submission to the IRB in order to obtain its approval for the clinical trials to proceed. Act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, etc., • This position requires regular interaction with a variety of internal and external contacts including Cancer Center investigators and staff, IRB staff, study sponsors and/or their representatives., • Bachelor's degree, • 2 years of experience in clinical research Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in La Jolla,CA. Application Deadline This position is anticipated to close on Feb 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

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 Quality Systems Specialist (Veeva) is responsible for supporting Capricor’s transition to the Veeva electronic Quality Management System (eQMS) and providing ongoing system administration, configuration, and maintenance. This role plays a key part in ensuring the eQMS meets GxP, regulatory, and operational requirements while enabling efficient and compliant quality processes.The Specialist will support implementation activities, system configuration, validation, user support, continuous improvement, and cross‑functional collaboration. This is a highly visible role critical to Capricor’s modernization of quality systems and digital infrastructure.Responsibilities * eQMS Transition & Implementation • Co‑lead the transition from the legacy QMS to Veeva eQMS, supporting planning, execution, and go‑live readiness., • Participate in system implementation activities including:, • Gathering and documenting user and business requirements (URS)., • Configuration of Veeva Vault Quality modules (QMS, Docs, Training)., • Data migration planning, mapping, execution, and verification., • Coordinate and support system validation activities (IQ/OQ/UAT), including documentation and testing oversight., • Support hypercare and post‑implementation stabilization activities., • Configure and maintain quality workflows, lifecycles, roles, permissions, and security settings., • Manage configuration of Veeva processes including Deviations, CAPA, Change Control, Training, and Document Control., • Maintain metadata structures, document hierarchies, and controlled vocabulary., • Serve as a Veeva eQMS System Administrator for Capricor., • Support Veeva releases by performing impact assessments, regression testing, and required documentation updates., • Manage system issues, enhancements, and change requests in partnership with Veeva Support., • Identify opportunities to enhance system usability, workflow efficiency, and user experience., • Analyze system metrics (cycle times, overdue items, trending data) to drive optimization., • Conduct user training sessions, onboarding, and refresher training for Veeva Vault applications., • Serve as a Veeva eQMS Subject Matter Expert (SME) to support end users with troubleshooting and best practices., • Provide guidance on system usage to ensure compliance and data integrity.Required Skills, • Education & Experience: Bachelor’s Degree and 5+ years of experience in a pharmaceutical, biologics, or FDA‑regulated environment., • Certification: Veeva Vault certifications (Administrator, Quality Suite) or equivalent hands‑on experience administering and configuring Veeva Vault., • Quality Background: Minimum 3+ years of Quality Assurance or Quality Systems experience in a GMP‑regulated environment., • Regulatory Knowledge: Knowledge of GxP regulations and industry guidance including 21 CFR Part 11, 210, 211, and ICH Q8/Q9/Q10., • Technical Skills: Experience supporting system implementation, validation, configuration, and release management activities., • Soft Skills: Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non‑technical stakeholders., • Tools: Proficiency with Microsoft Office applications.Preferred / Nice-to-Have Skills, • Experience migrating from a legacy QMS to Veeva Vault., • Understanding of electronic signatures, data integrity principles, and audit trail requirements., • Experience working with IT, Validation, and QA teams on system qualification activities., • Prior involvement in developing SOPs, workflows, or training content for eQMS systems., • Strong analytical and problem‑solving abilities with experience interpreting system metrics.Work Environment / Physical Demands, • Primarily office‑based with extensive computer use for system configuration, documentation, and administration., • Ability to sit for extended periods while working on system or documentation tasks., • Occasional lifting of materials up to 15 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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 Senior Director, Quality Assurance & Quality Systems provides strategic and operational leadership for all quality activities supporting Capricor’s clinical-stage and advancing commercial-stage organization. This role has full accountability for the design, execution, and continuous improvement of the Quality Management System (QMS) to ensure sustained regulatory compliance, inspection readiness, and robust quality oversight across development, manufacturing (including cell therapy production), and potential commercialization of Deramiocel and StealthX™-based programs. The Senior Director partners closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to enable late-stage development, BLA submissions and responses (including addressing any quality-related aspects of the Deramiocel pathway), commercial readiness, and scalable growth while embedding a proactive, risk-based quality culture across the enterprise.Responsibilities • Define and execute the enterprise quality strategy aligned with late-stage clinical development, BLA/regulatory submissions, potential commercial launch, and post-approval lifecycle management for cell and exosome-based therapies., • Serve as the senior Quality leader and strategic advisor to executive and operations management on compliance matters, inspection readiness, quality risk management, and GxP expectations in a biotech environment., • Own and continuously enhance the enterprise QMS to support clinical, manufacturing, and commercial operations, including Document Control and Change Management, Deviations/Investigations/CAPA, Training and Qualification, Data Integrity and Records Management, and other core quality processes., • Ensure quality systems are phase-appropriate, scalable, efficient, and fully aligned with FDA GMP regulations (21 CFR Parts 210/211, 820, and biologics-specific guidance), ICH guidelines, ISO standards, and global expectations for advanced therapies., • Ensure ongoing compliance with FDA, GMP, and applicable global regulations for clinical trials, manufacturing, and potential commercial activities, including cell therapy and exosome platforms., • Lead preparation for, management of, and response to regulatory inspections (including PAIs), partner audits, and health authority interactions; act as the primary Quality representative during agency engagements and inspections., • Provide comprehensive quality oversight for clinical quality assurance, including GCP compliance and support for ongoing trials such as HOPE-3 extensions or related activities., • Oversee quality support for manufacturing, testing, process validation, technology transfer, comparability studies, and supply chain activities for late-stage and commercial products (e.g., Deramiocel cell therapy production)., • Ensure timely and effective resolution of quality events, deviations, CAPAs, complaints, and out-of-specification results, with appropriate escalation, root cause analysis, and management visibility., • Collaborate closely with Clinical, Regulatory Affairs, CMC/Process Development, Manufacturing, Supply Chain, Quality Control, and Commercial teams to integrate quality principles throughout the product lifecycle and enable efficient, compliant decision-making., • Establish, monitor, and report quality KPIs, trends, risk indicators, and compliance metrics to senior leadership and the Quality Management Review., • Drive continuous improvement initiatives, including process optimizations, lessons learned from inspections/audits, and enhancements to strengthen compliance maturity, operational efficiency, and inspection outcomes., • Build, lead, and mentor a high-performing QA and Quality Systems organization; develop talent, succession plans, and training programs to support organizational scaling and commercialization milestones., • Foster a collaborative, accountable, and inspection-ready mindset across the quality team and broader company.Requirements, • Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred., • 12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments, with significant focus on biologics, cell therapies, or advanced therapy medicinal products., • 7+ years of senior leadership experience with direct ownership and oversight of enterprise Quality Management Systems in a growing organization., • Hands-on experience supporting late-stage clinical programs, BLA submissions, pre-approval inspections (PAIs), and commercial readiness/launch activities for regenerative medicine or biologics products., • Deep knowledge of FDA regulations (including 21 CFR Parts 210/211, 820, biologics-specific guidance), GMP, ICH guidelines (Q8-Q12, etc.), and global standards relevant to cell and exosome therapies., • Demonstrated success leading regulatory inspections (PAIs, routine GMP inspections), responding to findings, and maintaining inspection readiness in dynamic settings., • Proven ability to scale QMS and quality organizations in a rapidly growing biotech company preparing for commercialization., • Strong executive presence with the ability to influence, collaborate with, and advise cross-functional teams and senior leadership., • Excellent communication, problem-solving, decision-making, and strategic thinking skills.Work Environment / Physical Demands, • Office-based with routine presence in GMP manufacturing and laboratory environments to support oversight, audits, inspections, and quality activities., • Extended periods of computer use for documentation review, data analysis, metrics reporting, and quality system management., • Occasional lifting of office or light materials up to 10 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.