Manager, Manufacturing Support, Sterile Drug Product
Core
Lead the startup and operational support for a commercial biologics drug product facility, ensuring technical readiness, validation, and continuous improvement for sterile manufacturing processes.
Role type
Manager, Manufacturing Support (Sterile Drug Product)
Builds
Commercial biologics drug product facility (vial and syringe fill finish)
Domain
Biopharmaceuticals / Sterile Drug Manufacturing
Required skills
Sterile drug product manufacturing expertise, Technical troubleshooting, Complex investigation leadership, Change control management, Operational Excellence (5S, Kaizen), Regulatory inspection support, Training program development, Risk assessment, SOP/OJT development, MES/MBR design, Planning and scheduling
Preferred skills
Start-up experience, New product introduction (NPI) experience, Technical transfer experience, Proficiency in TrackWise and SAP systems
Technologies
TrackWise, SAP, MES, MBR
Responsibilities
Provide SME leadership for sterile processes (Formulation, Filling, Lyophilization, Capping, Visual Inspection), Lead CQV, Technical Transfer, and Operational Readiness activities, Drive change controls, CAPAs, and investigations, Develop training programs and documentation, Support Operational Excellence initiatives, Lead audits and batch disposition, Mentor manufacturing support team members
Seniority
Manager, hands-on IC with team leadership
