- 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 of the Operations...for pipeline programs from a Chemistry, Manufacturing, and Controls ( CMC ) perspective. They will lead the Product Presentation and… 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
- 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)
- …patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality ... the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC , and the wider PDM Quality organization. The successful candidate must have… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Executive Director , PDM Product Strategy Leader** **KEY RESPONSIBILITIES** Reporting to the ... this role leads strategic cross-functional teams responsible for all technical and CMC aspects of the assigned products, from entry into the technical development… 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
- Catalent Pharma Solutions (San Diego, CA)
- **Title: Director Product Development** **About Catalent San Diego:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... is seeking a dynamic leader to join us as Director , Product Development. The Director , Product Development...objectives. + Provide direction for the development of drug CMC efforts including toxicology and human studies. + Communicate… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …tomorrows. **Job Description** Kite is recruiting a highly experienced and strategic ** Director in our Viral Vector Process Design** (PDe) organization based in ... viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering… more