Lead Specialist, Sterility Assurance
Core
Lead aseptic filling operations and sterility assurance practices for biologics and viral vector products in a GMP manufacturing environment.
Role type
Senior IC sterility assurance specialist (biopharmaceutical manufacturing)
Builds
Aseptic drug products and viral vectors for clinical and commercial supply
Domain
Biopharmaceutical manufacturing / Sterility Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing, Environmental monitoring, Contamination control strategies, Microbiological analysis, GMP compliance, Deviation investigations, Change control, Risk assessment, SOP development, Validation support
Preferred skills
Failure Mode and Effects Analysis (FMEA), New Product Introduction
Technologies
HEPA filter certification systems, Aseptic gowning protocols, Media fill systems
Responsibilities
Lead aseptic filling operations and contamination control strategies; Execute sterility assurance strategy including environmental monitoring and cleaning programs; Interpret microbiological results from media fills and sterility testing; Lead deviation investigations and change controls; Provide technical support for new filling lines during design and validation; Serve as subject matter expert for regulatory inspections.
Seniority
Senior, hands-on IC
