- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule ... + Provides support for designated regional regulatory activities for PDM CMC Project and Commercial Teams, Regulatory Project and Regulatory Submissions Teams,… more
- AbbVie (Irvine, CA)
- …Description Further develop your expertise and join our team as Director, CMC Product Development. Must have Medical Device experience. The Product Development ... be responsible for pipeline programs from a Chemistry, Manufacturing, and Controls ( CMC ) perspective. They will lead the Product Presentation and Device Strategy… 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
- Deloitte (San Jose, CA)
- …experience + 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like GenAI, AI/ML, ... Veeva Vault RIM, Lorenz docuBridge, MasterControl, or similar); and + Involvement with CMC modules (Module 3 of CTD/eCTD) for global submissions, as well as… more
- Astellas Pharma (South San Francisco, CA)
- …using standard methods. + Proven expertise with protein drug development in CMC group. + Extensive experience in viral, cell and molecular biological technologies ... including but not limited to cell-based assay, DNA cloning, PCR, ELISA, Western etc. Expertise with range of biological methodologies consistent with ICH guidelines for quantifying purity/quality of viruses, proteins or DNA. + Success designing experiments,… more
- LGC Group (Petaluma, CA)
- …Axolabs is a business unit of LGC, and a leading provider of CRO / CDMO capability to the therapeutic oligonucleotide discovery and development industry. Centred out ... of LGC's site in Kulmbach, Germany, Axolabs works closely with its customers to assist the identification and development of lead candidates with a broad suite of bioinformatics, biology, chemistry, manufacturing and analytical services that support discovery,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …into the clinic. The successful candidate is expected to serve as the CMC analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he ... sit in our Foster City, CA headquarters. **Responsibilities:** + Lead CMC Analytical sub-team (as ASTL) to identify molecule CQAs, design/justify/execute end-to-end… 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