- Merck & Co. (North Wales, PA)
- Job DescriptionThis Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the ... and guidance for combination products (Drug and Drug Device combinations).- The Associate Principal Scientist is responsible for the preparation and submission of… 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 our Company's ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our ... Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director ...+ Lead the preparation of risk assessments on major global CMC regulatory issues + Provides regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... vaccine licenses world-wide + Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal… 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
- Bristol Myers Squibb (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
- Merck (North Wales, PA)
- **Job Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the ... and guidance for combination products (Drug and Drug Device combinations). The Associate Principal Scientist is responsible for the preparation and submission of… 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
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner ( Associate Director /Senior Manager) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... faster and more efficiently. As an Associate Director /Senior Manager Product Owner for in silico CMC...dynamic team committed to driving strategic digital priorities in Global R&D. This role involves developing digital product strategies,… more
- Merck (West Point, PA)
- **Job Description** We are seeking a highly motivated individual for the role of Associate Director , Biologics Down Stream Process Lead within the Enterprise Go ... Chain. The end-to-end scope includes Drug Substance for all large molecules. The Associate Director is expected to contribute to ongoing business process… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Product Development Princeton, NJ, USA Req #448 Thursday, March 6, 2025 Looking for a chance to make a meaningful difference in the oncology ... we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other....is the role for you. Position Summary: + The Associate Director , Product Development will be responsible… more
- Lilly (Indianapolis, IN)
- …of the scorecards with the 3rd parties. The key responsibilities for a business/operations Associate Director or Director may include: + Works with BRD, ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...from vendors by effective communication between vendor, finance and CMC PM teams. + Manage the collection of performance… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... scale-up/optimization for Ph3 and commercial launches. **Responsibilities:** The Assoc. Director of TS/MS enables Operational Excellence by ensuring strong… more
- Sanofi Group (Morristown, NJ)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our Company's ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- BeiGene (Emeryville, CA)
- **General Description:** The Associate Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology ... cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop,… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being ... than 110 countries and regions. **Summary:** Grifols is looking to hire Global Program Leaders (GPLs) to support drug development programs across its therapeutic… more
- Sanofi Group (Cambridge, MA)
- …experience. The successful candidate will work in a cutting-edge scientific global crystallization department in Sanofi's R&D CMC Synthetic organization. ... **About the Job** We are an innovative global healthcare company with one purpose: to chase...(Digital Twins) for batch and continuous process and use Global System Analysis tools (eg gPROMS) to identify CPPs,… more
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