Senior Manager, QC Microbiology

Celgene•Summit, NJ

3d•$134,630 - $163,142

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Sr. 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 Sr. Manager QC Microbiology is responsible to act as the SME during regulatory inspections.

Requirements

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, 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.
Bachelor's degree required, preferably in Microbiology or related science.
7 years' relevant Quality work experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring setting.
2-3 years of leadership/managerial experience required.
Must have experience in supporting sterile compounding, filling operations or cell therapy.
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.

Nice To Haves

Advanced degree preferred.
Experience working with cell therapy products is preferred.

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 Senior 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.
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

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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