- Gilead Sciences, Inc. (Foster City, CA)
- …serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… 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 ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … 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, CA. ... South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct hire **Salary:** $245,000-285,0000 **Position Overview**… more
- AbbVie (South San Francisco, CA)
- …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 ... in a highly collaborative approach. Reporting to the Director of Scientific Architecture, CMC , he/she will work closely with data architects and platform owners to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …The Scientist, Cell Culture Process Development (Pre-Pivotal) will lead and execute cell culture process development for Gilead biologics entities during pre-pivotal ... phases development (pre-clinical, phase I/II), including experimental design, laboratory execution, and process transfer. He/she will also lead and execute laboratory experimentation for cell culture process technology development, platform process evolution… 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 ... Operations & Submissions** Oversee the drafting, review, and approval of CMC sections for regulatory filings. Provide leadership for agency interactions,… more
- AbbVie (South San Francisco, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie has a long and rich history of ... art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC … more
- Gilead Sciences, Inc. (Foster City, CA)
- …rapidly growing Foster City team. A solid understanding of GMPs and CMC requirements is expected. Mass Spectrometry expereince is a must.** **Responsibilities:** + ... overseeing all analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +… more
- Bristol Myers Squibb (San Diego, CA)
- …programs at RayzeBio. This role will help to drive the CMC radiopharmaceutical process development for RayzeBio's novel pipeline. The radiopharmaceutical development ... scientist will assist with the CMC development plan and IND enabling activities, leading to...clinical drug product specifications and manage the execution of CMC studies. **Responsibilities:** Essential duties and responsibilities include the… more