Specialist, Technical Documentation, Cell Therapy Manufacturing in Devens, MA

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.

Bristol Myers Squibb Cell Therapy Manufacturing is seeking a Specialist Technical Documentation Cell Therapy Manufacturing who can bring enthusiasm intellectual curiosity scientific rigor and a desire to help drive novel programs. The candidate must be goal-oriented flexible and able to work collaboratively with safety and quality in mind. We are searching for passionate and innovative individuals with a strong understanding of current good manufacturing practices to support the creation revision and approval of all procedures and related documentation for Cell Therapy operations.

BMS Values

• Our values move us toward our mission to discover develop and deliver innovative medicines that help patients prevail over serious diseases.
• Candidates must exemplify the BMS values of Passion Integrity Inclusion Accountability Innovation and Urgency:

Passion

• Demonstrate dedication to quality and accuracy in documentation understanding the critical role these play in advancing patient care
• Engage with team members and SMEs to support shared goals with enthusiasm and commitment

Urgency

• Performs functions following all SOPs and compliance standards.
• Supports manufacturing in meeting deadlines for documentation updates.

Innovation

• Support process improvement initiatives identifying opportunities to improve GMP documentation and close compliance gaps
• Able to propose new ideas or methods to streamline document creation and compliance.

Accountability

• Take responsibility for assigned tasks from initiation to completion consistently meeting deadlines and quality standards.
• Own documentation workflows and associated quality actions and drive to completion.

Integrity

• Exhibit attention to detail by ensuring documentation is accurate and adheres to regulatory guidelines internal policies and ethical standards.
• Maintain compliance through diligent adherence to established procedures escalating concerns when necessary.

Inclusion

• Collaborates cross-functionally and contributes to a culture of inclusion and diversity.

Shifts Available:

TBD

Responsibilities:

• Author and revise Standard Operating Procedures (SOP) and associated documentation for cell therapy manufacturing in accordance with Current Good Manufacturing Practices (cGMPs).
• Work closely with department SMEs to align on procedural updates tech transfers and ensure proper reviewers/approvers on all documentation
• Accountable for ensuring quality and regulatory compliance of Manufacturing GMP documentation.
• Work as a liaison between manufacturing Quality Operations and relevant Management systems.
• Assist with Tech Transfer activities.
• Communicate to all functional area managers and supervisors Quality-related initiatives and actions.
• Must have the ability to challenge and make recommendations.
• Escalate compliance concerns to management in a timely manner.
• Review and approve change controls as the manufacturing representative.
• Communicate with team support resources and management regarding issue identification and resolution.
• Develop solid understanding of quality and documentation systems (BMSDocs and Infinity)
• Identify manage and own quality actions as required.
• Develop solid understanding of Cell Therapy Manufacturing processes.
• Tracks deliverables and manages timelines effectively.
• Supports internal/external audits taking urgent action to support requests.
• Assist with team metrics identifying improvements & ensuring prompt action is taken.
• Obtain access to and develop solid understanding of various electronic systems utilized by Manufacturing (MES SAP ValGenesis DeltaV Maximo etc.).

Minimum Requirements:

• Education: A Bachelors Degree in a related field is preferred. A combination of education and relevant experience may be considered in lieu of degree.
• Experience: 3 years in a Biotechnology/Pharmaceutical Manufacturing Operations or Support role. Knowledge of cGMP and manufacturing production is preferred. Experience authoring cGMP documentation and Cell Therapy manufacturing experience is preferred.

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If you come across a role that intrigues you but doesnt 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 employees 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 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 Years 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.

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 . Visit 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.

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