Supervisor, Manufacturing- First Shift
Core
Lead manufacturing technicians to execute Drug Substance engineering and PPQ batches, supporting the start-up of a new commercial manufacturing train and ensuring GMP compliance.
Role type
Manufacturing Supervisor (Start-up & Operations)
Builds
Commercial Drug Substance manufacturing train and production batches
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
GMP compliance, team leadership, equipment commissioning, process troubleshooting, batch record review, deviation investigation, safety management, production planning
Preferred skills
MES/eBR execution and design, SAP, LIMS, electronic document management systems
Technologies
SAP, LIMS, MES, eBR, Microsoft Office
Responsibilities
Recruit, hire, onboard, and train manufacturing technicians; Support equipment commissioning, qualification testing, and Factory Acceptance Tests; Create and approve GMP documentation including SOPs and batch records; Monitor processes and troubleshoot upset conditions; Evaluate production plans and resolve scheduling conflicts; Perform batch record reviews and support deviation investigations and root cause analysis; Maintain inspection-ready areas and support audits/regulatory inspections.
Seniority
Mid-level, hands-on IC with team management