Manager, QC Microbiology CAR T

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Shift schedule will be Wednesday - Saturday, 2nd shift (2 pm - 12pm)

PURPOSE AND SCOPE OF POSITION:

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 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.

DUTIES AND 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 eQRMS 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.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

Advanced knowledge of cGMP's, 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 has 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.

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, etc.
• Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
• An equivalent combination of education of experience may substitute.

WORKING CONDITIONS (US Only):

• 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

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.