- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...experience including experience as an RA CMC product lead with late stage development , international… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Implement global CMC regulatory strategies to enable life-cycle product /process development strategy while maintaining global licensure and right to ... in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is...and Skills** + Lead the execution and influence the development of global CMC regulatory strategies, including… more
- Takeda Pharmaceuticals (Boston, MA)
- …organization to think proactively and utilize science and risk based approach to product development and LCM activities. + Contribute to creating and ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- Amicus Therapeutics (Marlow, OK)
- Director , CMC RA Location Marlow, UK...Professional Work Experience Requirements + 10+ years' experience in CMC product development , regulatory. + ... Regulatory Affairs, Technical Operations, Science and Quality Assurance. + Ensure CMC development strategies are aligned with global regulatory expectations.… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC -...+ Serves as regulatory CMC representative on development and marketed product teams. + Responsible ... global programs from pre-approval or post-marketing. + Capability to interact with CMC technical experts regarding process development and analytical issues. +… more
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing coaching and feedback… more
- AbbVie (North Chicago, IL)
- …respect to time and budget. + Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard ... the clinical/regulatory development strategy and provide drug development experience and advice to the CMC ...planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... early and late phase drug development candidates within the team to support overall CMC development plan. - Represent CMC development project teams… more
- BeiGene (Emeryville, CA)
- …cell therapy development . Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will ... cell therapies is a plus. + Broad understanding of all aspects of CMC including process development , regulatory and quality requirements, analytical … more