Position Summary
The Director/Associate Director of QC Microbiology is responsible for leading the Quality Control Microbiology function supporting sterile injectable manufacturing operations. This role oversees microbiological testing, environmental monitoring, contamination control, sterility assurance, investigations, laboratory operations, and regulatory compliance to ensure product quality and patient safety. The position serves as the site microbiology subject matter expert and supports aseptic processing, contamination control strategy, and inspection readiness.
Key ResponsibilitiesLaboratory Leadership
- Lead day-to-day QC Microbiology laboratory operations supporting sterile manufacturing.
- Manage staffing, training, performance, budgets, laboratory inventory, and equipment.
- Develop and mentor microbiology personnel while ensuring operational excellence.
Microbiological Testing
- Oversee sterility, endotoxin, bioburden, microbial limits, and antimicrobial effectiveness testing.
- Manage microbial identification programs, isolate libraries, reference cultures, and media qualification activities.
- Ensure compliance with USP and regulatory requirements.
Environmental Monitoring & Utilities
- Lead environmental monitoring programs for classified manufacturing areas.
- Establish sampling plans, alert/action limits, and trend analysis programs.
- Oversee microbiological monitoring of WFI, purified water, clean steam, and process gases.
Contamination Control & Sterility Assurance
- Own and maintain the site Contamination Control Strategy.
- Lead media fills, aseptic process support, cleanroom qualifications, and sterilization validation activities.
- Oversee disinfectant efficacy studies, cleaning programs, and contamination control initiatives.
Investigations & CAPA
- Lead investigations involving EM excursions, sterility positives, endotoxin OOS results, and contamination events.
- Perform root cause analysis, risk assessments, and CAPA development.
- Support deviations, change controls, and quality system activities.
Training & Aseptic Practices
- Develop and deliver aseptic technique, gowning, and contamination control training.
- Conduct routine observations of aseptic operations and drive continuous improvement.
- Maintain personnel qualification and requalification programs.
Compliance & Regulatory Support
- Serve as microbiology SME during FDA inspections, audits, and customer assessments.
- Author and approve SOPs, protocols, reports, investigations, and trend analyses.
- Ensure data integrity, Part 11 compliance, and ongoing inspection readiness.
QualificationsRequired
- Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, or related field.
- 10+ years of microbiology experience in sterile pharmaceutical manufacturing.
- 5+ years of leadership experience in QC Microbiology.
- Strong expertise in environmental monitoring, aseptic processing, sterility assurance, and contamination control.
- Experience supporting FDA inspections and regulatory compliance activities.
Preferred
- Master's degree in a scientific discipline.
- Experience with isolators, rapid microbiological methods, and sterile injectable manufacturing.
- Knowledge of EU GMP Annex 1, sterilization validation, and contamination control programs.
Key Competencies
- QC Microbiology Leadership
- Sterility Assurance & Contamination Control
- Environmental Monitoring
- Aseptic Processing
- Regulatory Compliance & CGMP
- Investigation & CAPA Management
- Inspection Readiness
- Team Leadership & Development
- Data Integrity & Documentation
- Continuous Improvement
What Success Looks Like
- Maintain a compliant, inspection-ready microbiology program.
- Ensure timely and reliable microbiological testing and environmental monitoring.
- Strengthen contamination control and sterility assurance programs.
- Minimize recurring microbiological deviations through effective CAPAs.
- Build a high-performing microbiology team that supports product quality, patient safety, and operational excellence.
