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

• 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.

Qualifications

• 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.

• Experience working with cell therapy products is preferred.

• 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

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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

0Work-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.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science1d, 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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.