- Gilead Sciences, Inc. (Foster City, CA)
- …and inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is ... This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking a Director of CMC Quality for a direct hire opportunity with a leading biopharmaceutical company in South San Francisco, ... in South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct...regulatory and quality standards. Reporting to the Executive Director of Quality Assurance, you'll collaborate with various GxP… more
- Gilead Sciences, Inc. (Foster City, CA)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Kelly Services (South San Francisco, CA)
- …management across our investigational and commercial portfolio. Reporting to the Senior Director of CMC , you'll be instrumental in overseeing API process ... Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for...scale-up, regulatory strategy, and operational excellence required for clinical and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... in a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer Skills**… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly ... collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners. In addition,… more