Senior Manager Sterility Assurance, Qc Microbiology

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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 rich in diversity. Take your career farther than you thought possible.

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The Sr. Manager, Sterility Assurance QC Microbiology, is a highly critical role and is responsible for managing the QC Sterility Assurance initiatives, which support the CAR T manufacturing site.

This department is responsible for microbiological support-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, Sterility Assurance QC Microbiology is responsible for acting as the SME during regulatory inspections.

Responsibilities:

• Regular communication to senior levels of management
• Own and manage CAPAs, Change Controls and other quality records utilizing the site QRM system.
• Collaborate with peers in the cell therapy network to align practices
• Manage sterility assurance projects
• Serve as a sterility assurance subject matter expert
• Lead collaboration events with process experts, and quality teams
• Author study reports
• Perform analysis of microbiological data and prepare recommendations

Required Skills/Knowledge:

• Experience of new equipment qualification activities: URS, IQ, OQ, PQ, PVs, etc.
• Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines
• Demonstrated resource management and planning skills
• Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to the manufacturing of cell therapy products.
• Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc
• Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills
• Advanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.
• Demonstrated critical reasoning, problem-solving, troubleshooting, investigation, and decision-making skills
• Understanding of environmental monitoring program, Aseptic gowning, tools and techniques.
• Advanced knowledge of Microsoft Word, Outlook, Excel, PowerPoint, etc.
• Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site
• Advanced verbal and written communication skills
• Intermediate understanding of statistics, control charts, action, and alert limits.
• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment
• Advanced data integrity knowledge and practices.

Requirements:

• 7 years of Quality Microbiology work experience in a cGMP
• Experience in performing and leading Risk Assessments
• At least 2 years of leadership/managerial experience (An equivalent combination of education of experience may substitute)
• Bachelor’s degree

Preferred Requirements:

• Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
• Experience working with cell therapy products
• Experience in supporting sterile compounding and filling operations.
• Bachelor’s degree in Microbiology
• Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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