Senior Manager, QC Microbiology

Role Summary

Senior Manager, QC Microbiology leads the QC Microbiology Laboratory supporting the CAR-T manufacturing site, overseeing microbiological testing of in-process samples, final product testing, critical utilities sampling, validation and requalification support, and incoming components testing. Ensures testing meets FDA, MHRA, PMDA, EU and other regulations; serves as the SME during regulatory inspections. Location: Summit West, NJ, US.

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 the critical utilities systems.
• Develop and manage SOPs, forms, and methods required to support compliant operation and testing in the Microbiology laboratory.
• Ensure that all materials, products, methods, and equipment are within specifications and ensure accurate and timely disposition of test results and investigations.
• Ensure that microbiology lab test results which exceed specification limits are submitted as deviations in the eQRM system, investigated, and CAPAs are implemented.
• Ensure site and department objectives are met; manage and schedule microbiology laboratory personnel to meet manufacturing schedules; ensure employees are trained and qualified; provide performance evaluations and support career development of direct reports.
• Perform other tasks as assigned.

Qualifications

• 7 years of relevant Quality experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring setting; experience with cell therapy preferred.
• 2-3 years of leadership/managerial experience required.
• Must have experience in supporting sterile compounding, filling operations or cell therapy.
• Experience participating and supporting regulatory audits (FDA, MHRA, PMDA, etc.) preferred.
• Experience working with Quality Systems (SOPs, Change Control, Deviations, CAPAs, and Risk Assessments) preferred.
• An equivalent combination of education and experience may substitute.

Education

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

Skills

• Advanced knowledge of cGMPs, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations 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 and able to work cross-departmentally throughout the manufacturing site.
• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
• Advanced mentoring and coaching, influencing, negotiating and personal interaction skills.
• Demonstrated resource management and planning skills; flexible and adaptable, able to work under pressure and meet deadlines.
• Advanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment (lockout/tagout), fall safety, HAZCOM, MSDS sheets, etc.

Additional Requirements

• The incumbent will be required to work in an office and Microbiology laboratory environment.
• The incumbent will be required to gown for entry into aseptic core and supporting areas, as needed.
• On-call availability to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
• Occasional travel may be required.