- Vera Therapeutics (Brisbane, CA)
- Job Description Title: Executive Director , Translational Research Biology Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as… more
- AbbVie (Irvine, CA)
- …. Job Description Further develop your expertise and join our team as Director , CMC Product Development . Must have Medical ... Device experience. The Product Development Director (PDD) will be a member...requirements, budget and resources. + Multiple product development experiences of leading a CMC team… more
- 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 (Emeryville, CA)
- …of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development , manufacturing, Quality, etc. including minimum 8 years ... team in US. * Lead or/and oversee the development and implementation of biologics regulatory CMC ...or/and oversee regulatory risk assessment, identify key biologics regulatory CMC issues and mitigation activities needed throughout product… 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
- 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)
- …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)
- …manufacturing, or supply chain, or quality, or CMC regulatory, or process development , or as part of a cross-functional product team in the broader ... 35 countries worldwide, with headquarters in Foster City, California. **Executive Director , PDM Product Strategy Leader** **KEY RESPONSIBILITIES** Reporting to… 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
