- 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 ... onsite in South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct hire **Salary:** $245,000-285,0000… 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 ICH ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… 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
- AbbVie (South San Francisco, CA)
- …required by the Use Cases in a highly collaborative approach. Reporting to the Director of Scientific Architecture, CMC , he/she will work closely with data ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Scientist II, CMC Data Strategy is a multidisciplinary expert who partners with Development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …lives of patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), ... Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC , and the wider PDM Quality organization....Chain, RA CMC , and the wider PDM Quality organization. The successful candidate must have experience in… 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 regulatory ... Cultivate strong, collaborative relationships across Gilead's global functions, including Quality , Manufacturing, Technical Development, Clinical Development, and Supply Chain.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality , Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical ... **Job Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial… more
- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global ... collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports, investigator… more
- Roche (South San Francisco, CA)
- …technical functions + Are responsible for authoring, reviewing and/ or submission of high- quality CMC regulatory documents to health authorities + Represent PTR ... new medicines to patients? We are seeking a Technical Regulatory Program Director to join our Pharma Technical Regulatory (PTR) department. This position plays… 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...(CROs), and key vendors to ensure consistent, compliant, and high- quality API supply. + Operational Excellence: Initiate and implement… more
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