- Regeneron Pharmaceuticals (Rensselaer, NY)
- …our team and play a pivotal role in supporting manufacturing, quality, and CMC Regulatory (Chemistry, Manufacturing, and Controls) activities. This position is ... Work closely with departments such as Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory to manage the process lifecycle effectively. + Author… more
- AbbVie (Irvine, CA)
- …(TPP), Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures ... brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and… more
- Takeda Pharmaceuticals (Boston, MA)
- …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Management Systems (QMS) to assure the site/division is compliant with regulatory , Corporate, and customer requirements. They are responsible for establishing and ... Quality. The Director of Quality is responsible for providing project guidance and support and work with customers to...business partner to Operations and advisor to the General Manager of the site. Location: Kansas, City, MO on-site… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Senior Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as ... **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more
- Sanofi Group (Northborough, MA)
- …requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions + Knowledge and experience with ... coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations *...and purchasing systems in a CGMP manufacturing environment + Project management skills + Expertise in document management systems… more
- Astrix Technology (San Diego, CA)
- …and day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); ... technical documentation + Perform analytical data review to ensure compliance with regulatory and quality standards + Manage and execute stability studies + Support… more