Lead Biotechnologist (Central Services)
Core
Leads cGMP manufacturing operations for biologics production, specifically managing central services streams including buffer/media preparation, autoclaving, glasswashing, and cleaning processes.
Role type
Senior IC biotechnologist (central services)
Builds
Biologics parts, components, and final materials
Domain
Biopharmaceutical manufacturing
Required skills
cGMP manufacturing operations, shift leadership, troubleshooting, process validation, safety risk assessment, batch documentation, regulatory audit preparation, team coaching, LIMS/SAP/DeltaV/POMSnet systems, sterile processing
Preferred skills
Innovation in process streamlining, independent problem solving, multi-tasking in fast-paced environments
Technologies
LIMS, SAP, DeltaV, POMSnet, automated control systems
Responsibilities
Execute manufacturing operations using validated programs, lead operations and troubleshooting during shifts, ensure safety compliance and conduct hazard analyses, maintain audit-ready plant conditions, coach and train biotechnologists, resolve anomalous processing events, prepare for regulatory audits
Seniority
Senior, hands-on IC with shift leadership