- 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
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- Job Title Associate Director , Manufacturing Operations Requisition JR000015470 Associate Director , Manufacturing Operations (Open) Location Horsham, PA ... Additional Locations Job Description Summary Job Description The Associate Director , Manufacturing Operations will provide leadership and management of operations at… more
- Organon & Co. (Jersey City, NJ)
- …authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on...to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early ... Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS Translational… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC , and the Gilead Site Quality to achieve ... Join Gilead and help create possible, together. **Job Description** **Senior Director , Global Supplier Quality** Gilead Sciences, Inc. is a research-based… more
- Bristol Myers Squibb (Cambridge, MA)
- …late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision ... for both internal and external opportunities. + Participates in regulatory filings (NDA, BLA filings) as well as develops...evidence. + Supports commercial needs and recommendations to guide CMC and GPS on trade packaging and commercial product.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …PDM functions including Product and Portfolio Strategy, Global Manufacturing,Supply Chain, Regulatory CMC , and the wider Quality organization to achieve ... Join Gilead and help create possible, together. **Job Description** **Senior Director ,** **External Q** **uality Testing** **Operations** This role can be based… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Senior Director Project Mgmt - Oversight** At Thermo Fisher Scientific,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: Foster ... City_** **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more