Senior Manager, Manufacturing Operations
Core
End-to-end business process owner for commercial GMP manufacturing operations, leading the startup of a new drug substance manufacturing train and managing multiple shifts for production and launch.
Role type
Senior Manager, Manufacturing Operations
Builds
Commercial GMP manufacturing train, production schedules, and operational readiness for drug substance
Domain
Pharmaceutical/Biotech manufacturing (oligonucleotide/Drug Substance)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing operations)
Required skills
GMP manufacturing, team building, project management, SAP, equipment commissioning, lean manufacturing, regulatory compliance, KPI establishment, hiring and training
Preferred skills
MES/eBR, PI Historian, LIMS, process automation
Technologies
SAP, MES, eBR, PI Historian, LIMS
Responsibilities
Plan and manage operational readiness and PPQ execution for new manufacturing train; Lead SAP design and implementation for commercial manufacturing; Execute equipment commissioning and qualification testing; Design and implement electronic logbooks and batch records within MES; Hire, train, and manage multiple shifts for daily production; Establish KPIs to maximize schedule adherence; Partner with Quality functions for batch record review and CAPA management; Participate in regulatory agency audits and inspections.
Seniority
Senior Manager, hands-on leadership
