Manager, QC Microbiology (Sterile Drug Manufacturing & Fill Finish)

Key Responsibilities

• 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.

Qualifications

• Required:
• 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.
• 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.