QC Microbiology Manager
Core
Lead GMP QC-Micro laboratory operations and strategic ownership of the Contamination Control Program at a biological Drug Substance clinical manufacturing facility.
Role type
Senior IC QC Microbiology Manager
Builds
GMP-compliant biological drug substances and antibody-based medicines
Domain
Biotechnology / Clinical Manufacturing / Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
GMP QC microbiology leadership, contamination control strategy, environmental monitoring, utilities monitoring, microbial method development, contamination investigation, aseptic technique mentorship, deviation/OOS investigation, data integrity (ALCOA++)
Preferred skills
Experience with Contract Manufacturing Organizations (CMOs), cell banking oversight, adventitious agent testing (mycoplasma, viral)
Technologies
None explicitly listed beyond general lab equipment
Responsibilities
Lead all Microbiology operations including bioburden, endotoxin, microbial ID, and water testing; Coordinate Disinfectant Efficacy (DET) studies; Oversee external microbiological testing and approve results; Provide technical SME oversight of GMP cell banking; Troubleshoot microbiological assays and contamination events; Lead investigations of microbiology-related deviations; Verify QC data packages for ALCOA++ compliance; Mentor QC team on aseptic practices; Ensure inspection readiness; Interface with auditors; Collaborate with cross-functional teams; Create and adhere to SOPs
Seniority
Senior, hands-on IC