Senior Manager, Sterility Assurance

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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.

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.

Position Summary

The Sr. Manager, Sterility Assurance is a highly critical role and is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site. This role is responsible for supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, the gowning certification/recertification program, critical utilities sampling and testing, and overall contamination control program for the site. The Sr. Manager Sterility Assurance is responsible to act as the SME during regulatory inspections.

Duties/Responsibilities

• 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.
• Ensure the execution and support of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs.
• Generate, own, and/or support change controls, deviations, CAPAs within the eQMS system.
• Support equipment, facility, and microbiological method qualifications.
• Ensure the site and department objectives are met.
• Manage and develop direct reports.
• Onboard new materials required to support manufacturing operations.
• Support 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.
• Incumbent must gown for entry into Aseptic core and supporting areas, as needed.
• Management incumbent or designee will be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
• Occasional travel may be required.
• Perform other tasks as assigned.

Qualifications

• 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 and data trending.
• Advanced knowledge of Microbiology.
• Intermediate knowledge of Good Engineering Practices and Validation Principles (URS, IQ, OQ, PQ, PVs, etc.).
• Advanced verbal and written communication skills.
• Critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Team-oriented and ability to work cross-departmentally throughout the manufacturing site.
• Leadership and management skills, including establishing direction and goals, guiding execution while fostering a team-based environment.
• Mentoring and coaching, influencing, negotiating and personal interaction skills.
• Resource management and planning skills.
• Flexible and adaptable, 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 proficiency in Microsoft Word, Outlook, Excel, PowerPoint.
• Microbiology laboratory and/or Environmental Monitoring setting.
• Experience working with cell therapy products is preferred.
• 2‑3 years of leadership/managerial experience…