- AbbVie (South San Francisco, CA)
- …8, Masters with 6, or PhD with 3 years of CMC biologics functional experience. + Senior Manager : Bachelors with 10, Masters with 8, or PhD with 5 years of ... that are compliant with global regulatory requirements. Partners with CMC teams during the development of CMC ...with CMC teams during the development of CMC control strategies. Implement well-defined, efficient processes for preparation… more
- 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 ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy across the… more
- BeOne Medicines (San Mateo, CA)
- …**:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level compliance ... guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations manages… 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)
- …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)
- …+ 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