Job Description

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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. 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. Read more: careers.bms.com/working-with-us

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.

Duties/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.

Qualifications

Specific Knowledge, Skills, Abilities:

• 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.

• Knowledge of cell therapy manufacturing is highly desirable.

Education/Experience/ Licenses/Certifications:

• 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.

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.

Compensation Overview:

Devens - MA - US: $100,480 - $121,756

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 https://careers.bms.com/life-at-bms/.

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.

​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.

*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 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 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.

Supporting People with Disabilities

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 adastaffingsupport@bms.com Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601044 : Manager, Sterility Assurance