Manager, Sterility Assurance

Bristol Myers Squibb • Devens, MA

2d

About The Position

The Manager, Sterility Assurance role is responsible for overseeing and driving continued compliance of the site contamination control program. This includes, but is not limited to, facility design and facility modifications, the aseptic process validation program, aseptic observer program, aseptic gowning and operator qualification programs, and the environmental and clean utility monitoring programs. This role will directly collaborate cross-functionally with internal and external stakeholders to deliver exceptional results and drive continuous improvement of the sterility assurance control systems and processes at the site.

Requirements

• Advanced understanding of Microbiology and aseptic processing.
• Experience with/understanding of common QC Microbiology and environmental/clean utility monitoring procedures, techniques, and laboratory methods.
• Experience with EM/CU monitoring and/or EM/CU program development.
• Experience with/understanding of facility control systems (e.g., HVAC, utilities, DPs, cleaning and disinfection).
• Knowledge and understanding of US and EU cGMP regulations and guidance.
• Demonstrated experience applying quality risk management principles per ICH Q9 to contamination control systems, including routine facility and utility monitoring.
• Proficiency with quality management systems and processes, including SOPs, Change Control, Deviations, and CAPAs.
• Strong critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills under pressure.
• Must be team-oriented with the demonstrated ability to work independently and collaborate cross-functionally.
• Must be flexible, adaptable, and able to work under pressure, while meeting designated timelines.
• Experience with internal and regulatory inspections preferred.
• Advanced technical writing and verbal and written communication skills.
• Bachelor's degree in STEM field preferred.
• High school diploma/Associates degree with equivalent combination of education and work experience may be considered.
• A minimum of 6 years’ experience in an environment governed by cGMPs, preferably with at least 3 years’ experience in QC Microbiology and/or sterility assurance roles.

Nice To Haves

• Knowledge of cell therapy manufacturing is highly desirable.

Responsibilities

• Ensures the execution and support of the contamination control strategy for the facility including, but not limited to aseptic processes, facility design and modification, gowning certification/recertification program, environmental monitoring and clean utility systems design and modification, and EMPQs.
• Ensures all sterility assurance activities comply with applicable regulatory requirements (e.g., FDA, EMA, USP) and BMS policies.
• Serves as Sterility Assurance SME for projects, continuous improvement initiatives, and Quality Risk Management programs.
• Generates, owns, reviews, and/or acts as SME for document revisions, change controls, deviations, proactive initiatives, CAPAs etc. within the eQMS systems.
• Supports metrics and data analysis, including generation/review of EM/CU trend and capacity ramp reports.
• Oversees the environmental monitoring, clean utility monitoring, aseptic process simulation, aseptic performance qualification, aseptic observer, and aseptic gowning programs.
• Supports equipment, facility, and microbiological method validation and qualifications.
• Develops and facilitates routine Environmental Action Committee governance meetings.
• Authors and/or reviews of filing submissions and updates.
• Performs final review of root cause analysis EM deviations.
• Ensures site and department objectives are met.
• Supports onboarding of new materials required for manufacturing operations.
• Acts as SME during regulatory inspections and responds to all regulatory inquiries in a timely manner.
• Provides support for manufacturing and production issues, questions, and triage meetings.
• Actively participates in global forums and project teams.
• Will be occasionally required to be on call during holidays or off shift activities.
• The incumbent will be required to routinely gown into the manufacturing cleanroom and maintain gowning qualification for the aseptic processing areas.
• Actively contributes to the continuous improvement and development of site programs and processes.
• Maintains and facilitates cross-functional relationships and collaboration.
• Occasional travel may be required.
• Performs other tasks as required.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees