Senior Manager, Microbiology (CVRM)
Core
Establish and lead the QC Microbiology team for a new greenfield drug manufacturing facility, focusing on laboratory start-up, qualification, and future commercial operations for CVRM medicines.
Role type
Senior Manager, QC Microbiology (Greenfield Start-up)
Builds
A compliant, efficient QC Microbiology organization supporting the launch and operation of a new pharmaceutical manufacturing plant.
Domain
Pharmaceutical manufacturing / Biopharmaceuticals / Cardiovascular, Renal, and Metabolism (CVRM)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology methods, laboratory instrumentation, analytical method validation, contamination control strategies, environmental monitoring, cGMP operations, ICH guidelines, global regulatory requirements, project management, budget management (OpEx/CapEx), team leadership, strategic project execution
Preferred skills
Greenfield project experience, Operational Excellence certification (Lean Six Sigma, 5S, Kaizen)
Technologies
Laboratory instrumentation, digital tools, real-time data analytics
Responsibilities
Establish core QC capabilities for facility and process qualifications, author and approve critical technical and compliance documents, own QMS records including investigations and CAPAs, present Microbiology topics during regulatory inspections, manage operational and capital budgets, drive continuous improvement and safety culture
Seniority
Senior Manager, hands-on IC with strategic leadership