Manager, Technical Lead, Sterile Drug Product (Manufacturing)
Core
Provide on-the-floor technical leadership and act as a Subject Matter Expert (SME) for aseptic manufacturing processes in a new sterile drug product facility.
Role type
Senior Technical Lead / Manufacturing SME
Builds
Commercial sterile drug products (vials and syringes) via fill-finish and lyophilization
Domain
Pharmaceutical manufacturing (Sterile Drug Products)
Required skills
Aseptic manufacturing, GMP compliance, process troubleshooting, validation (CQV), commissioning, lean manufacturing, process automation systems, SOP development
Preferred skills
Sterile facility experience, formulation knowledge, visual inspection, MES/MBR design, operational excellence tools (5S, Kaizen)
Technologies
Delta V, Syncade Interactions, OSI/Pi Historian, SAP, Trackwise, Maximo
Responsibilities
Lead technical issue troubleshooting, support commissioning and validation, develop training materials and SOPs, drive continuous improvement initiatives, coordinate batch review reports, build team technical competencies
Seniority
Senior, hands-on IC