- Gilead Sciences, Inc. (Foster City, CA)
- …DESCRIPTION** + Leads a team of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio of projects from early development ... + A scientific degree with directly relevant professional experience in biologics product development , global CMC regulatory affairs, and CMC technical areas… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidances, comments on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- BeOne Medicines (San Mateo, CA)
- …critical issues to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory guidance and working + ... consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Join Kite and help create more tomorrows. **Job Description** We are looking for a Sr Director , Analytical Operations to join our team at our Kite headquarters ... cross functional team + Design, develop, execute and document analytical method development and qualification in support of process development , product release… more
- Humana (Sacramento, CA)
- …with business partners to uphold ethical standards and mitigate risks. The Senior Clinical Compliance Professional will support the Director of Compliance, ... a part of our caring community and help us put health first** CenterWell Senior Primary Care (PCO) is a growing provider organization that currently operates about… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr . Director , Regulatory Affairs will serve as the therapeutic area head ... trials as well as Life Cycle Management Strategies. The Sr . Director will work closely with the...on North and South America + Experience with biologics, CMC , Toxicology, Orphan Drugs development , breakthrough and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a team of ... lifecycle: early development , late-phase and commercialization, and commercial. The Senior Director , Product Management Team Lead (Early Phase) will have… more
- AbbVie (Irvine, CA)
- …business strategy. Responsibilities: *Serves as an in-house expert in identification and development of consumer eye care products. As required by program needs, in ... partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May participate in or lead clinical … more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role responsible for overseeing and driving the ... highly regulated industry and will interact at all levels, including BeOne's Senior Management. This role blends deep expertise in regulatory affairs with… more
- BeOne Medicines (Emeryville, CA)
- …in a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development , GMP and regulatory requirements **Computer Skills** ... **_General Description:_** Sr . Manager/Associate Director , Supply Chain CMO...with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, Supply Planning to ensure manufacturing performance, cost… more
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