- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- BeOne Medicines (Emeryville, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing, managing and improving all aspects of purchasing ... Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC Development partners to ensure supply continuity with optimal...supply continuity with optimal cost and quality. Finally, the Senior Procurement Manager will help drive the… more
- Amgen (Thousand Oaks, CA)
- …and transform the lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this. Let's change the ... Amgen's Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Senior Scientist. The successful candidate will join us on our effort to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …day and improving the lives of patients for generations to come. As a ** Senior Manager , Global External Manufacturing** at Gilead you will + Support ... 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)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senor Manager , Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and ... process improvements to build the organization for the future. The Senor Manager , Clinical Supply Chain leads staff and provides leadership and guidance during… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: ... within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director, Product Management Team Lead** will lead a team of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …day and improving the lives of patients for generations to come. As a Senior Research Associate at Gilead you will + Plan and successfully execute experiments and ... as well as identity and report inconsistent results to manager or supervisor + Participate in group meetings and...fields with 2+ years of industrial experience in biologics CMC development + Hands on experience working with biologic… more