- Actalent (Greenfield, IN)
- Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC Regulatory Affairs Scientist , you will play a crucial role in the ... + Collaborate with pharmaceutical development and industrial operations teams to generate CMC regulatory dossiers. + Participate in industry working groups to… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in...and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in...molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. +… more
- Organon & Co. (Plymouth Meeting, PA)
- …applicants.** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... overseeing all analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... We are seeking a talented and highly motivated Principal Scientist for our Pivotal and Commercial Biologics Characterization team...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... Analytical Operations department is seeking a highly motivated Senior Scientist to lead our impurities development team. The ideal...program. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization ... true to the best of my knowledge. **Job Description** **Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG** **Location: Cambridge, MA** **About… more
- Merck (Rahway, NJ)
- …including Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical ... **Job Description** Scientist (R2) Biologics Analytical **North American GMP Operations,...individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D)… more
- AbbVie (North Chicago, IL)
- …with many groups external to PDS&T, for example: Manufacturing Operations, Regulatory Affairs , Quality Assurance, etc. Responsibilities: . Effectively functions ... . Authors and/or reviews technical reports, manufacturing batch records and regulatory documents concerning Chemistry, Manufacturing and Control ( CMC ) subjects.… more
- Bristol Myers Squibb (Seattle, WA)
- …for GMP manufacturing + Expertise in late-stage biologics PD + Working knowledge of regulatory affairs as they relate to biologics and ATMPs + Working knowledge ... personal lives. Read more: careers.bms.com/working-with-us . **Job Description** The Senior Scientist will join the Gene Delivery and Editing Process Development… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development, and Technical ... Description** We are seeking a talented and highly motivated **Research Scientist ** to join our **Pivotal and Commercial Biologics Characterization** team within… more
- Merck (Rahway, NJ)
- …Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges, ... seeking an enthusiastic individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Pharmacology, Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC , Regulatory Affairs , Patient Safety and ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Sanofi Group (Cambridge, MA)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate.… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC , Biostatistics, GCO, in the execution ... plan, working closely with Disease Area Head, Clinical Development Lead, Clinical Scientist . and other functional areas such as GCO, biostats, regulatory ,… more
- System One (Park Ridge, NJ)
- …+ Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements ... and Sterilization understanding + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC + Strong knowledge of QbD principles and… more