Senior Manager, QC Microbiology
Core
Lead GMP QC-Micro operations at a biological Drug Substance clinical manufacturing facility, ensuring contamination control and regulatory compliance for antibody-based medicines.
Role type
Senior Manager, QC Microbiology
Builds
GMP-compliant biological drug substances (antibody-based medicines)
Domain
Biotechnology / Clinical Manufacturing / Microbiology
Required skills
GMP QC microbiology leadership, contamination control strategy, environmental monitoring, microbial methods, contamination investigations, team mentoring, external lab oversight, risk-based testing, data integrity (ALCOA++)
Preferred skills
Strategic planning, cross-functional partnership, troubleshooting complex microbiological events, scientific decision-making
Technologies
GMP, ALCOA++, bioburden testing, endotoxin testing, microbial identification, growth promotion, Disinfectant Efficacy Testing (DET), mycoplasma testing, viral testing
Responsibilities
Lead and develop the QC Microbiology team; define and execute contamination control and microbiological method strategies; oversee internal operations including water testing and environmental monitoring; coordinate resources across internal and external testing; lead troubleshooting and investigations for deviations and OOS results; partner with QA, Manufacturing, and CMC to ensure compliant execution.
Seniority
Senior Manager, hands-on leadership