- Takeda Pharmaceuticals (Boston, MA)
- …DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for a direct hire opportunity with a leading ... Senior Director , $275,000 - $320,000 **Overview** As Associate Director / Director , Drug...our investigational and commercial portfolio. Reporting to the Senior Director of CMC , you'll be instrumental in… more
- Bristol Myers Squibb (Seattle, WA)
- …for: + Technology transfer and process validation across the product lifecycle + CMC lifecycle management and regulatory strategy + Oversight and governance of ... harmonization, and standardization to ensure global manufacturing scale-up, reliability, and regulatory compliance We are seeking a strong strategic technical leader… more
- Bristol Myers Squibb (Summit, NJ)
- …strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions. The Sr. Principal Engineer will support commercial product ... but not limited to, continued process verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class… more
- Merck (West Point, PA)
- …BLAs.- The successful candidate will be responsible for strategic partnering with CMC development, Regulatory , Quality, and our partners in commercialization and ... and ensure safety and quality of our products. The Director of Vaccines Potency in Analytical Research & Development...be responsible for a team of 10-15 senior and associate level scientists. The position is accountable for developing… more
- Lilly (Indianapolis, IN)
- …lifecycle of an asset ranging from the discovery/development interface through regulatory submission and post-approval changes. We work to improve patient outcomes ... Overview:** We are seeking a veteran and visionary Sr. Director of Early Phase Chemistry to join our leadership...programs at CDMOs. This role will report to the Associate Vice President in SMDD. **Key Responsibilities** _People &… more
- University of Maryland, Baltimore (Baltimore, MD)
- …This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and Controls ( CMC ); Clinical Research; ... of Pharmaceutical Sciences with teaching responsibility to the Graduate Program Director and Associate Dean for Graduate Programs. *_ACADEMIC RESPONSBILITIES… more