Manager, QC Microbiology, Cell Therapy

Position Summary

The Manager, QC Microbiology, is a highly critical role and is responsible for managing the QC Microbiology Laboratory which provides support to the CAR T manufacturing site. This department is responsible for microbiological related testing of in-process samples, final product testing, critical utilities sampling and testing, 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 Manager QC Microbiology is responsible to act as the SME during regulatory inspections. PM Shift: Wednesday to Saturday 2 PM 12 AM

Duties/Responsibilities

• Manage QC Microbiology department.
• Management and coordination of the Microbiological Laboratory testing program and scheduling to ensure timely testing and results, to support final product testing and release, incoming components and materials testing and release, and monitoring of the critical utilities systems.
• Development and management of SOPs, forms, and methods required to support the compliant operation and testing conducted in the Microbiology laboratory.
• The Manager, QC Microbiology, plays a critical role in ensuring that all materials, products, methods and equipment are within specifications and ensuring accurate and timely disposition of test results and compliance investigations.
• Ensure that Microbiology lab test results which exceed the specification limits, are submitted as a Deviations in the eQMS system, investigated, and effective CAPAs are implemented.
• Ensure the site and department objectives are met.
• Manage and develop direct reports.
• Management and scheduling of Microbiology laboratory personnel within the department to meet the Manufacturing schedule and needs.
• Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports.
• Perform other tasks as assigned.

Job Safety Requirements and Essential Physical Demands

The Manager role is responsible for supporting and training staff on activities that may include the following:

• Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height.
• Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or maneuver carts to transport materials between locations.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
• Ability to independently don, doff, and wear required personal protective equipment such as but not limited to lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
• Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials.
• Ability to work in a Biosafety Level 2 (BSL-2) environment.

Qualifications

Education and Experience:

• Bachelor’s degree required, preferably in Microbiology or related science. Advanced degree preferred.
• 7 years’ relevant work experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring.
• Experience working with cell therapy products are preferred.
• 2 years of leadership experience preferred.
• Must have experience in supporting sterile compounding and filling operations.
• Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, and TGA.
• Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
• An equivalent combination of education or experience may substitute.

REQUIRED COMPETENCIES

• Advanced knowledge of cGMPs, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as 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, validations/suitability studies etc.
• 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 have the demonstrated ability 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.
• Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines.
• Advanced knowledge of safety, OSHA, and EPA regulations.
• Electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.
• Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc

WORKING CONDITIONS

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, on an as-needed basis. The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations. Occasional travel may be required.