- Gilead Sciences, Inc. (Foster City, CA)
- …improving the lives of patients for generations to come. As a **Senior Manager , Global External Manufacturing** at Gilead you will + Support uninterrupted supply of ... represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy across the… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Amgen (Thousand Oaks, CA)
- …such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will actively chart the ... opportunities to advance their own career in partnership with their manager . **Key Responsibilities Include:** + Lead analytical method lifecycle management… more
- Stantec (Sacramento, CA)
- …produce project deliverables that meet project requirements and the project manager and client's expectations. Work consists of advanced mechanical design for ... and plumbing. Your Key Responsibilities - With direction from a project manager and/or Professional Engineer Design, develop, and optimize mechanical and plumbing… more
- Parexel (Sacramento, CA)
- Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global ... regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life Sciences, Chemistry,… more
- AbbVie (Irvine, CA)
- …Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures that the AST ... advisor to cross-functional teams (eg, Global Commercial Team, Global Brand Team, CMC , Integrated evidence strategy team, Value and Access team, Regulatory strategy,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …variances and concerns as well as identity and report inconsistent results to manager or supervisor + Participate in group meetings and efforts by presenting data ... or related scientific fields with 2+ years of industrial experience in biologics CMC development + Hands on experience working with biologic products is strongly… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as a subject matter ... with FDA/EMA guidance for preclinical and early clinical phases. + CMC awareness: Understanding of drug substance/product development and manufacturing timelines. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Participates in solving issues of high complexity. + Communicates issues to line manager and project teams in a timely manner + Support product team needs for ... and project management software + Understanding of activities related to the CMC development of biopharmaceuticals + Advanced knowledge of GMPs and associated… more
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