Associate Director, External Drug Product Manufacturing

RoleAssociate Director overseeing aseptic drug product manufacturing at CMOs, supporting both clinical and commercial production demands. Responsibilitiesprovide on-site oversight (person-in-plant) manage forecasting request quotations liaise with clinical and commercial teams for product planning onboard new CMOs review master and batch records investigate deviations review invoices QualificationsBachelor’s or Master’s in Engineering or Biological Sciences 5-8 years managing aseptic fill operations at CMOs or in-house experience with internal and external resources knowledge of secondary packaging, batch record writing, and regulatory compliance in cGMP environments High-Valueaseptic biopharmaceutical manufacturing (vials, pre-filled syringes) quality standards validation project management international travel (~10-20%) cGMP batch records SOPs WorkSetupglobal travel required