• Director , CMC Regulatory Affairs…

    Gilead Sciences, Inc. (Foster City, CA)
    …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
    Gilead Sciences, Inc. (08/15/25)
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  • Director of CMC Quality

    Kelly Services (South San Francisco, CA)
    Kelly(R) Science & Clinical is seeking a Director of CMC Quality for a direct hire opportunity with a leading biopharmaceutical company in South San Francisco, ... Hybrid, onsite in South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct hire **Salary:** $245,000-285,0000… more
    Kelly Services (08/21/25)
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  • Associate Director , Regulatory CMC…

    BeOne Medicines (San Mateo, CA)
    …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
    BeOne Medicines (06/25/25)
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  • Director , Regulatory Affairs CMC

    Gilead Sciences, Inc. (Foster City, CA)
    …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
    Gilead Sciences, Inc. (06/27/25)
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  • Senior Scientist II, CMC Data Strategy

    AbbVie (South San Francisco, CA)
    …required by the Use Cases in a highly collaborative approach. Reporting to the Director of Scientific Architecture, CMC , he/she will work closely with data ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Scientist II, CMC Data Strategy is a multidisciplinary expert who partners with Development… more
    AbbVie (08/14/25)
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  • Exec Director , Regulatory…

    Gilead Sciences, Inc. (Foster City, CA)
    …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory ... Operations & Submissions** Oversee the drafting, review, and approval of CMC sections for regulatory filings. Provide leadership for agency interactions,… more
    Gilead Sciences, Inc. (08/08/25)
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  • Director , Biologics Analytical Development…

    Gilead Sciences, Inc. (Foster City, CA)
    …**Job Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial ... Foster City team. A solid understanding of GMPs and CMC requirements is expected. Mass Spectrometry expereince is a...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with… more
    Gilead Sciences, Inc. (07/18/25)
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  • Exec Director , Formulation & Process…

    Gilead Sciences, Inc. (Foster City, CA)
    …Join Gilead and help create possible, together. **Job Description** **Executive Director , Formulation and Process Development** + The Executive Director ... + Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance… more
    Gilead Sciences, Inc. (08/20/25)
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  • Associate Director , Small Molecule…

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... ensure compliance with applicable regulations and guidelines. + Provide CMC functional representation on wider cross-functional program development teams, ensuring… more
    Otsuka America Pharmaceutical Inc. (08/27/25)
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  • Director , Quality

    Gilead Sciences, Inc. (Foster City, CA)
    …patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality ... the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC , and the wider PDM Quality organization. The successful candidate must have… more
    Gilead Sciences, Inc. (08/08/25)
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