• Director , Regulatory Affairs…

    Gilead Sciences, Inc. (Foster City, CA)
    …on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with… more
    Gilead Sciences, Inc. (06/27/25)
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  • Associate Director , Regulatory…

    BeOne Medicines (San Mateo, CA)
    …assigned projects. 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...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
    BeOne Medicines (06/25/25)
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  • Senior DMPK Director (Drug…

    System One (Alameda, CA)
    …and build comprehensive DMPK packages to enable successful drug registration. The senior director is responsible for providing strategic and technical subject ... and oversight for the DMPK support of several programs in portfolio. The Senior Director contributes to growth of the Clinical Pharmacology and Pharmacometrics… more
    System One (08/29/25)
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  • Senior Director , Product Management…

    Gilead Sciences, Inc. (Foster City, CA)
    …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
    Gilead Sciences, Inc. (08/08/25)
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  • Senior Scientific Director…

    AbbVie (Irvine, CA)
    …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
    AbbVie (08/08/25)
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  • Director of API Manufacturing

    Kelly Services (South San Francisco, CA)
    …external partnership management across our investigational and commercial portfolio. Reporting to the Senior Director of CMC , you'll be instrumental in ... Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for...overseeing API process scale-up, regulatory strategy, and operational excellence required for clinical and… more
    Kelly Services (08/29/25)
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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 ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
    Otsuka America Pharmaceutical Inc. (08/27/25)
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  • Director , Viral Vector Process Design

    Gilead Sciences, Inc. (Santa Monica, CA)
    …development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly ... collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners. In addition,… more
    Gilead Sciences, Inc. (06/08/25)
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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 ... and understanding to support product robustness targets + Serve as a senior member of the Technical Development Leadership Team responsible for developing and… more
    Gilead Sciences, Inc. (08/20/25)
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  • Exec Director , Program Strategy Leader

    Gilead Sciences, Inc. (Foster City, CA)
    …in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional ... 35 countries worldwide, with headquarters in Foster City, California. **Executive Director , PDM Product Strategy Leader** **KEY RESPONSIBILITIES** Reporting to the… more
    Gilead Sciences, Inc. (07/15/25)
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