Position OverviewThe QC Microbiology Manager leads the daily operations of the Microbiology Laboratory supporting sterile drug product manufacturing and fill-finish operations. This role ensures that environmental monitoring, microbiological testing, and contamination control programs meet regulatory expectations and maintain a state of control across aseptic processing areas. The ideal candidate brings strong technical expertise in microbiology, proven leadership skills, and deep understanding of sterile manufacturing and fill-finish processes.
Key ResponsibilitiesMicrobiology Laboratory Leadership- Supervise and mentor microbiologists and laboratory analysts, ensuring high technical competency and adherence to cGMP.
- Oversee scheduling, workload prioritization, and resource planning to support manufacturing and fill-finish operations.
- Ensure laboratory operations comply with FDA, EMA, ICH, and Annex 1 requirements.
- Maintain a culture of data integrity, continuous improvement, and operational excellence.
Aseptic & Fill-Finish Support- Serve as a technical lead for Aseptic Process Simulations (Media Fills). This includes designing "worst-case" simulation protocols, managing the incubation and inspection of units, and investigating any failures to identify root causes.
- Provide microbiology expertise for aseptic processing, sterile filtration, filling operations, lyophilization, and visual inspection.
- Lead oversight of environmental monitoring (EM) programs for cleanrooms, isolators, RABS, and filling suites.
- Review and approve EM trend reports, sterility test results, bioburden data, endotoxin results, and water system monitoring.
- Partner with Manufacturing, QA, and Engineering to ensure contamination control strategies are robust and effective.
Compliance, Investigations & Quality Systems- Lead or support investigations for microbiology-related deviations, EM excursions, sterility failures, and contamination events.
- Develop and implement CAPAs to prevent recurrence and strengthen contamination control.
- Review and approve SOPs, test methods, validation protocols, and laboratory documentation.
- Support regulatory inspections and internal audits, serving as the subject matter expert for microbiology and aseptic controls.
- Ensure qualification and ongoing monitoring of clean utilities (WFI, clean steam, compressed gases).
Laboratory & Method Management- Oversee qualification, calibration, and maintenance of microbiology laboratory equipment (e.g., isolators, incubators, endotoxin systems).
- Ensure validated and compliant microbiological test methods, including sterility testing, endotoxin, bioburden, microbial ID, and growth promotion.
- Manage sample flow, chain of custody, and timely release of microbiological data to support production schedules.
- Drive continuous improvement initiatives to enhance testing efficiency, contamination control, and laboratory workflow.
QualificationsRequired- Bachelor's or master's degree in microbiology, Biology, or related Life Science discipline.
- 10+ years of QC Microbiology experience with at least 2 years in a supervisory or management capacity in a GMP sterile drug manufacturing environment.
- Direct experience with media fill validation, smoke studies, and environmental monitoring in Grade A/B (Class 100) environments.
- Strong knowledge of aseptic processing, contamination control, and fill-finish operations.
- Experience with environmental monitoring programs, sterility testing, Bacterial Endotoxin Testing, and cleanroom classification.
- In-depth understanding of the 2022 revised EU Annex 1, FDA 21 CFR 211, USP , , and , and ICH Q7-Q10.
- Demonstrated leadership experience, including coaching, training, and performance management.
- Excellent communication, documentation, and cross-functional collaboration skills.
Preferred- Experience with isolator-based sterility testing and aseptic filling technologies.
- Knowledge of rapid microbiological methods (RMM) and modern contamination control strategies.
- Experience supporting regulatory inspections (FDA, EMA, MHRA).
- Understanding of water system microbiology and clean utility qualification.
- Lean/Six Sigma or continuous improvement training.
Pay Range: $116,000 - $174,000 per year
