- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- Merck & Co. (Rahway, NJ)
- … Principal Scientist - Device Engineering and Early Development Lead ( Associate Director Equivalent)Our company's Device Development (DD) Team designs, ... working group and integrating device development activities into the overall CMC working group.Support assets in discovery. Identify and develop the combination… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a Senior Manager/ Associate Director , External Manufacture as part of the Global Manufacturing Supply team ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset,… more
- Novo Nordisk Inc. (Boulder, CO)
- …and external suppliers to ensure a smooth and timely delivery. Relationships Associate Director of Amidite Manufacturing. Owner of business relationships with ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Amicus Therapeutics (Marlow, OK)
- …Job Brief Associate Director CMC RA Amicus Therapeutics is a global , ... Associate Director CMC RA... Associate Director CMC RA Location Marlow, UK...Affairs, Technical Operations, Science and Quality Assurance . Ensure CMC development strategies are aligned with global … more
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Associate Director ** **; CMC , Device Development Program Manager** **Functional ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and… more
- AbbVie (North Chicago, IL)
- …through regular communications and periodic reviews throughout development and in support of global filings and approvals. + Represents all CMC areas on the ... of global filings. + Responsible for the global filings of high quality CMC dossiers,...for the global filings of high quality CMC dossiers, approvals and commercialization of products. Qualifications *Bachelor's… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and ... Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for...for Teva products, and for ensuring the quality of CMC response to global health authorities. The… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and made available throughout IOPS + Monitors and assesses all sources of global CMC intelligence information, including industry trends, for relevance and ... The Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio… more
- Sumitomo Pharma (Columbus, OH)
- …of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and ... ** Associate Director , GMP Quality Control** Sumitomo...release, change control and facility re-starts. + Partners with CMC to conduct method transfers and validation of new… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will be...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & Supply/Pharmaceutical ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… more
- Merck (West Point, PA)
- …Operations. We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule Technology Transfer within ... end-to-end scope includes Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to ongoing business process… more
- Sanofi Group (Framingham, MA)
- …Culture Development department within CCD located in Framingham, MA in the role of Associate Director . We are looking for a candidate with excellent scientific, ... **Position Summary** The global Cell Culture Development (CCD) organization within Sanofi operates...CMC , communication, and management skills to manage a team of… more
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