Associate Director, External Drug Product Manufacturing

Role: Associate Director overseeing aseptic drug product manufacturing at CMOs, supporting both clinical and commercial production demands. Responsibilities: provide 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, and review invoices. Qualifications: Bachelor’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-Value: aseptic biopharmaceutical manufacturing (vials, pre-filled syringes), quality standards, validation, project management, international travel (~10-20%), cGMP, batch records, SOPs. WorkSetup: global travel required.