- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Merck & Co. (Rahway, NJ)
- …Engineering or Science fields.-Required Experience and Skills:Bachelors Degree in life sciences or equivalent with at least 15 years of relevant experience, a ... Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC development and commercialization strategy which yields the target… more
- Merck & Co. (Rahway, NJ)
- …are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science , and technology, we collaborate to deliver the next medical ... to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our company's Research Laboratories (is committed to… more
- Merck & Co. (Rahway, NJ)
- …are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science , and technology, we collaborate to deliver the next medical ... to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... supply chain to-achieve launch on time and uninterrupted long-term supply.Represents CMC and effectively communicates across the governance bodies, stakeholders, and… more
- Novo Nordisk Inc. (Boulder, CO)
- …Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Boulder, Lexington, Watertown, ... Novo Nordisk against Custom's fines and penalties. This role ensures regulatory requirements are adhered to and proper documentation, including transit documents… more
- Merck & Co. (Rahway, NJ)
- …Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, cutting-edge science , and technology, we partner to deliver the next medical ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC ... skills are essential for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day might… more
- **Kelly Science has an Immediate opening for a Senior CMC Regulatory Sciences Specialist for our growing client near St. Louis, MO** Full-time Direct ... Compliance & Submissions** + Prepare, review, and submit high-quality postapproval CMC regulatory submissions and related correspondence to the FDA/CVM. +… more
- Lilly (Indianapolis, IN)
- …regulatory sciences leadership, decision making, guidance and coaching for CMC regulatory scientists. + Communicates regulatory decisions and strategy ... world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC )...or PhD in Chemistry, Biology, Engineering, or closely related science + 10+ years of experience in CMC… more
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