- Regeneron Pharmaceuticals (Cambridge, MA)
- …discussions with external and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic company guidance on FDA ... minimum of 10 years of progressively responsible experience in Regulatory Science CMC for biologics or 4 + years' experience in Cell & Gene Therapy /ATMPs. Does this… more
- Alloy Therapeutics (Waltham, MA)
- …capabilities that are foundational for discovering and developing therapeutic biologics . The company facilitates affordable, non-exclusive access to the entire ... Alloy and our affiliated venture studio, 82VS. The Role The Associate Director , Strategic Initiatives and Business Operations is a versatile and strategic operator… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Associate Director , Global Quality and Compliance Excellence uses advanced subject matter ... all global sites in the areas of small molecule pharmaceuticals, biologics , combination products, medical devices, tissue, and cosmetics for future inspections… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …help create more tomorrows. **Job Description** We are seeking a highly experienced Director of Analytical Operations to lead the Flow Assay Development Team within ... of cGMP and regulatory guidelines related to analytical methods for biologics /cell therapy. + Commercial experience in assay development for late-stage clinical… more
- AbbVie (North Chicago, IL)
- …. Job Description Purpose: The Senior Principal Research Scientist/ Director of Drug Metabolism and Disposition (Biotransformation) will lead ... of ADME and PK/PD science, experience with both small molecules and biologics . + Strong fundamental understanding of mass spectrometry and its strategic use… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** Join Takeda as a Director , Market Access and Channel Strategy out of our Lexington or Cambridge, MA Office. ... payer, PBM, IDN, GPO, Specialty Pharmacy highly preferred + Experience with biologics and specialty products preferred understanding of US payer market dynamics and… more
- Amgen (West Greenwich, RI)
- …us and transform the lives of patients while transforming your career. **Associate Director - Engineering Technical Authority** **What you will do** Let's do this! ... project execution. + At least 5 years working in or supporting a biologics drug substance manufacturing facility + Leadership of multi-functional teams to implement… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. **OBJECTIVES:** The Associate Director , IBD/GI Research, Drug Discovery working in the Gastroenterology Drug ... niche + Expertise in one therepaeutic modaility (small molecules, antibodies & biologics , ASOs/siRNA) and familiarity with other modalities + Demonstrated ability to… more
- Merck (Rahway, NJ)
- …+ Therapeutic area expertise in Oncology or Immunology. + Experience with biologics , vaccines, or mRNA therapeutics. + Significant regulatory affairs experience in ... major markets (US, EU, Japan, China). Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **US and Puerto Rico Residents Only:** Our… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs, and CMC technical areas ... of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD. + Demonstrated track record of defining innovative global CMC regulatory strategies applied across a portfolio of projects. + Experience with clinical submissions at all phases of… more