Senior Manager, QC Microbiology

Role Summary

The Sr. Manager, QC Microbiology is a highly critical role responsible for managing the QC Microbiology Laboratory which provides support to the CAR T manufacturing site. This department handles microbiological testing of in-process samples, final product testing, critical utilities sampling, validation and requalification support, incoming component testing, and microbiological identification. Sampling and testing must meet or exceed FDA, MHRA, PMDA, EU, and other governmental regulations or guidelines. The Sr. Manager QC Microbiology acts as the SME during regulatory inspections.

Responsibilities

• Manage and coordinate the Microbiological Laboratory testing program and scheduling to ensure timely testing and results, supporting final product testing and release, incoming components and materials testing and release, and monitoring of critical utilities systems.
• Develop and manage SOPs, forms, and methods required to support compliant operation and testing conducted in the Microbiology laboratory.
• Ensure all materials, products, methods, and equipment are within specifications and ensure accurate and timely disposition of test results and compliance investigations.
• Ensure microbiology test results exceeding specification limits are submitted as Deviations in the eQRM System, investigated, and effective CAPAs are implemented.
• Ensure site and department objectives are met.
• Manage and schedule microbiology laboratory personnel to meet the Manufacturing schedule and needs.
• Ensure employees are properly trained and qualified, provide performance evaluations, and support career development of direct reports.
• Perform other tasks as assigned.

Qualifications

• Required: Advanced knowledge of cGMPs, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines related to manufacture of cell therapy products.
• Advanced data integrity knowledge and practices.
• Intermediate understanding of statistics, control charts, action and alert limits.
• Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques.
• Intermediate knowledge of Good Engineering Practices and Validation Principles (URS, IQ, OQ, PQ, PVs, etc.).
• Ability to lead and maintain the development of Microbiology laboratory testing data and trending.
• Advanced verbal and written communication skills.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Must be team-oriented with the ability to work cross-departmentally across the manufacturing site.
• Demonstrated leadership and management skills, including establishing direction and goals, guiding execution, and fostering a team-based environment.
• Advanced mentoring and coaching, influencing, negotiating, and interpersonal skills.
• Demonstrated resource management and planning skills; able to work under pressure and meet timelines.
• Advanced knowledge of safety, OSHA, and EPA regulations, and familiarity with electrical/energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS, etc.

• Preferred: Bachelor's degree in Microbiology or related science; Advanced degree.
• 7 years of relevant Quality work experience, preferably in a Microbiology laboratory and/or Environmental Monitoring; cell therapy experience preferred.
• 2–3 years of leadership/managerial experience.
• Experience supporting sterile compounding, filling operations, or cell therapy.
• Experience participating in and supporting regulatory audits (FDA, MHRA, PMDA, etc.).
• Experience with Quality Systems (SOPs, Change Control, Deviations, CAPAs, Risk Assessments).
• Equivalent combination of education and experience may substitute.

Education

• Bachelor's degree required, preferably in Microbiology or related science.
• Advanced degree preferred.

Additional Requirements

• Working in an office and Microbiology laboratory environment; gowning for entry into aseptic core and supporting areas as needed.
• On-call to support manufacturing issues involving sampling or test excursions during shift operations.
• Occasional travel may be required.
• Site-essential roles require onsite presence; hybrid options may apply for site-by-design roles.