- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… 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, ... Hybrid, 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
- 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
- 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
- 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
- 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...Serve as a mentor and subject matter expert within CMC , fostering best practices in a multidisciplinary environment. **Qualifications**… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …**Job Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial ... Foster City team. A solid understanding of GMPs and CMC requirements is expected. Mass Spectrometry expereince is a...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Executive Director , Formulation and Process Development** + The Executive Director ... + Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... initiatives with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, Supply Planning to ensure manufacturing performance, cost objectives… more