Senior Manager, Sterility Assurance

Bristol Myers Squibb • Summit, NJ

22h

About The Position

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. 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. The Senior Manager, Sterility Assurance plays a critical role in ensuring 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. Generates, owns, and/or supports 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. 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. 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. Occasional travel may be required. Perform other tasks as assigned.

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 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
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills
• Must be team-oriented and has the demonstrated ability to work cross[1]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
• Microbiology laboratory and/or Environmental Monitoring setting
• 2-3 years of leadership/managerial experience required
• 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 and experience may substitute

Nice To Haves

• Experience working with cell therapy products is preferred

Responsibilities

• Support facility design/modifications
• Support the aseptic process validation program
• Support operator qualification/requalification
• Support the gowning certification/recertification program
• Support critical utilities sampling and testing
• Support overall contamination control program for the site
• Act as the SME during regulatory inspections
• Support final product testing and release
• Support incoming components and materials testing and release
• Support 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
• Generates, owns, and/or supports 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
• Perform other tasks as assigned

Benefits

• Medical, pharmacy, dental, and vision care
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed