Manager, Quality Engineering Cell Therapy

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 rich in diversity. 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 .

Employer: Bristol-Myers Squibb Company

Position: Manager, Quality Engineering Cell Therapy (Ref: 4214)

Location: 38 Jackson Road, Devens, MA 01434

Duties: Provide quality oversight, technical document review, and approval for the facility, equipment, utility commissioning and qualification, process validation, computer systems, and analytical validation documentation from technical, Health Authority regulations, and BMS policies by drawing on experience with Current Good Manufacturing Practices (cGMP) and regulatory requirements for validation of equipment, computerized systems, and drug manufacturing processes, DeltaV distribution control system (DCS) including configuration, programming, and troubleshooting, contamination control strategies, Medicinal Products Process Validation methodology, life cycle documents, manufacturing methodologies/principles, and cell therapy process, business systems, including SAP, LIMS (Laboratory Information Management System), Maximo, manufacturing executions systems (Syncade), distributive control systems (DeltaV), and PI Historian. Provide quality oversight on Technology Transfer initiatives for Cell Therapy products; verify compliance with applicable Health Authority, BMS Policies, Guidelines, and Directives and ensure consistency with other site procedures and specifications; review and approve process risk assessment FMEAs (Failure Mode Affect Analysis) documents and ensure all mitigation strategies are developed and implemented for risks to product quality throughout the product and process lifecycle; provide guidance, review, and approve the Cell Therapy APS (Aseptic Process Stimulation) risk assessments, study protocols, deviations, summary reports, and procedures/policies; support cross-functional departments MS&T (Manufacturing Science & Technology) planning of validation plan, testing methodology, and test activities; provide Quality oversight to the Devens Cell Therapy Aseptic Process Stimulation (APS) program, including the study strategy, quality risk assessment, investigations, and process improvements; review and approve requirement specifications in validating new or modified processes, systems that supports manufacturing in the plant i.e., User Requirements Specification, Functional Specification, System configuration specification, Design specification, using extensive working knowledge of quality concepts and internal procedures; respond to inquiries from audits and inspections from FDA and world health authorities; support the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems, and leads the local change review board; provide Quality impact assessment for Cell Therapy commercial change controls; review and approve the Subject Matter Experts /regulatory impact assessments for completeness and ensure the required actions are initiated to implement the proposed changes; review and approve the change control to ensure health authority and change action are adequately implemented and closed; provide guidance as Subject Matter Expert in the Change Control process; support site deviation investigations and complete implementation of CAPA (Corrective Action and Preventive Action) Actions; ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensure Validation Master Plan (VMP) adherence; demonstrate appropriate examples for compliance behaviors and attitudes, thereby shaping the culture; meet and exceed all safety expectations and adhere to all BMS behaviors; provide guidance and mentorship; identify, advocate for, and drive opportunities for continuous improvement. May work remotely 5 days every 2 weeks within normal commuting distance of Devens, MA.

Requirements: Bachelor's degree in pharmaceutical science, healthcare technology/engineering, or a related field plus 6 years of post-baccalaureate experience showing demonstrable ability in the skill set described above. The required skills do not need to be maintained over the full term of required experience.

The starting compensation for this job is a range from $114,088 to $134,484 stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 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 our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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.

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 an inclusive culture, promoting diversity 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

Responsibilities

BMS has a diverse 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.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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