Manager, QC Microbiology, Cell Therapy

Bristol Myers Squibb•Devens, MA

11d•$100,490 - $121,767•Onsite

About The 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 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. This role works the PM Shift: Wednesday to Saturday 2 PM - 12 AM.

Requirements

Bachelor’s degree required, preferably in Microbiology or related science.
7 years’ relevant work experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring.
Experience working with cell therapy products are preferred.
Must have experience in supporting sterile compounding and filling operations.
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.
Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, validations/suitability studies 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

Nice To Haves

Advanced degree preferred.
2 years of leadership experience preferred.
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.
Intermediate understanding of statistics, control charts, action and alert limits.
Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc.

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.
Ensure 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.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day