Manager, Technical Lead, Sterile Drug Product
Core
Provide on-floor technical leadership and SME support for aseptic manufacturing processes (Formulation, Filling, Lyophilization, Capping, Visual Inspection) in a new sterile drug product facility.
Role type
Senior IC Manufacturing Technical Lead
Builds
Commercial vial and syringe fill finish drug products
Domain
Biopharmaceuticals / Sterile Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic manufacturing expertise, GMP compliance, technical troubleshooting, process validation, lean manufacturing, process automation systems, batch reporting, operational excellence
Preferred skills
Biopharma manufacturing experience, shift work adaptability, capital project experience
Technologies
Delta V, Syncade Interactions, OSI/Pi Historian, SAP, Trackwise, Maximo
Responsibilities
Lead technical issue troubleshooting during and post facility start-up, support Commissioning/Qualification/Validation, develop SOPs and training materials, drive continuous improvement initiatives, coordinate batch review with QA, build team technical competencies
Seniority
Senior, hands-on IC
