- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... multiple products. + Lead the execution and influence the development of global CMC regulatory strategies, including...risk mitigation strategies to ensure right first-time approvals of product submissions. + Lead the execution of these global… more
- BeOne Medicines (San Mateo, CA)
- …consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory ... CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior...to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …scientific knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + ... 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
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Responsibilities** **1. Strategy and Roadmap Development ** + Define and continuously refine a CMC RA ... 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
- AbbVie (South San Francisco, CA)
- …a scientific discipline within CMC (analytical development , drug substance development , or drug product development ); must have a strong, scientific ... Data Strategy is a multidisciplinary expert who partners with Development Sciences scientists and leaders to identify and pursue...Cases in a highly collaborative approach. Reporting to the Director of Scientific Architecture, CMC , he/she will… more
- Catalent Pharma Solutions (San Diego, CA)
- **Title: Director Product Development ** **About Catalent San Diego:** Catalent, Inc. is a leading global contract development and manufacturing ... is seeking a dynamic leader to join us as Director , Product Development . The ...clients meet their objectives. + Provide direction for the development of drug CMC efforts including toxicology… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details. + Accountable for PAI/PLI readiness and supports Gilead ... of patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL),… more
- Gilead Sciences, Inc. (Foster City, CA)
- …late-phase portfolio. + Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product ... & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development … more
- Gilead Sciences, Inc. (Foster City, CA)
- …responsibility + In-depth knowledge and understanding of drug product development , commercial technology transfer to manufacturing, CMC related FDA and ... aspirations. Join Gilead and help create possible, together. **Job Description** **Executive Director , Formulation and Process Development ** + The Executive … more
- Gilead Sciences, Inc. (Foster City, CA)
- …and early clinical phases. + CMC awareness: Understanding of drug substance/ product development and manufacturing timelines. + Possess strong business acumen ... the broader Pharmaceutical Development and Manufacturing (PDM) organization, the **Senior Director , Product Management Team Lead** will lead a team of … more