- Gilead Sciences, Inc. (Washington, DC)
- …(internally and externally) for Quality Policy issues in conjunction with the Gilead CMC Regulatory Policy Office. The role will be focused primarily on ... authorities and cross-industry associations. + Matrix/coordinate/lead strategy development with CMC Regulatory Affairs Policy Advisory and Intelligence Office… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing ... best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for small-molecule… more
- Takeda Pharmaceuticals (Boston, MA)
- …Pharmaceutical Sciences counterparts. + Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for ... Description** **Title: Process Engineer Small Molecules API Process Science (Associate Director )** **Location: Cambridge, MA (Hybrid)** **About the role:** As a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and Operations and partner closely with Technical Development leadership, IT, Manufacturing, CMC Regulatory and the broader Gilead digital ecosystem. **Key ... **Job Description** **Head of Technical Development Data & Digital Team (Senior Director )** We are seeking a highly motivated individual to join the Technical… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Takeda Pharmaceuticals (Boston, MA)
- …roles, with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- University of Colorado (Aurora, CO)
- **IND/IDE Office Assistant Director ** **Description** **University** **of Colorado Anschutz Medical Campus** **Department: Clinical Research Operations and ... Collaborate with investigators, IRBs, research administration, and legal teams to navigate regulatory pathways for novel therapeutics and devices + Convene and lead… more
- Catalent Pharma Solutions (Kansas City, MO)
- ** Director , Quality, BioAnalytical** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, ... stand-alone and integrated biologics projects. Catalent Pharma Solutions is hiring a Director of Quality who is responsible for setting the strategic direction,… more
- Amgen (Cambridge, MA)
- …Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's ... leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team… more
- University of Utah (Salt Lake City, UT)
- …skills. + Previous experience in personnel management. + Must have experience with FDA regulatory writing and submissions including CMC sections, DMF , IND , and ... Details **Open Date** 12/09/2025 **Requisition Number** PRN43772B **Job Title** Director , Research & Science **Working Title** Director of Cyclotron Operations… more