- Daiichi Sankyo, Inc. (Bernards, 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 ... CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr ... product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...staff and infrastructure can support manufacture of materials for global clinical supplies. Finally, the individual will be responsible… more
- Bristol-Myers Squibb Company (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality ... Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds… more
- EPM Scientific (Rockville, MD)
- …and process design. Contribute to cross-contamination prevention initiatives across the Global Supply Chain (GSC), including the development of standards within the ... years of experience in biopharmaceutical process development, MSAT, or CMC roles. Extensive experience with commercial-scale cleaning validation and contamination… more
- Cytokinetics (South San Francisco, CA)
- …individuals who are driven to make a positive impact. Job purpose As the Associate Director of Toxicology, you will play a critical role in advancing ... closely with colleagues in Discovery Biology, Pharmacology, Medicinal Chemistry, DMPK, CMC and Clinical to drive our programs forward. Your strong analytical… more
- Shuvel Digital (Reston, VA)
- …Has supervisory and developmental responsibilities within a functional area. The program director manages one or more projects or programs, may manage an operating ... abilities. Desired Relevant Certifications: Project Management Professional (PMP) Certified Associate in Project Management (CAPM) Program Management Professional (PgMP)… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific ... processes. + Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials,… 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 ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory ... accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC … more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for ... of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate...and post marketing reports per US FDA regulations. The Associate Director , US Product CMC … more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal ... product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting… more
- J&J Family of Companies (Malvern, PA)
- …as a single submission. **We are searching for the best talent for an Associate Director , CAR-T Analytical Scientific Integrator - Advanced Therapies to be ... located in Malvern, PA or Leiden, Netherlands.** **Purpose:** The Associate Director , CAR-T Analytical Scientific Integrator will provide analytical, technical… 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 ... The position is responsible for a managing all aspects of global Contract Manufacturing partnerships, driving productivity through strategic initiatives with… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Drug Substance Commercial Development **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of ... progress. The Commercial Process Development team, part of the CMC Synthetics Platform within the Sanofi R&D organization, is...join our growing Commercial Process Development team as an Associate Director . Under the direction of the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced ... + Represent Analytical Development on cross-functional teams. + Author and review CMC documents for regulatory submissions and address global health authority… more
- RTX Corporation (Pueblo, CO)
- …**Security Clearance:** None/Not Required Collins Aerospace is seeking an experienced ** Associate Director of Carbon Engineering .** This position reports ... (AMF) as part of Troy, OH Landing Systems. The ** Associate Director of Carbon Engineering** and staff...fellows successors. + Partners with Carbon R&D and Collins Global Engineering Centers to leverage resources and knowledge to… more
