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

Bristol Myers Squibb • Devens, MA

3d • $44 - $53 • Onsite

About The Position

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. At 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, there’s 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.

Requirements

• A Bachelor’s Degree in a related field is preferred. A combination of education and relevant experience may be considered in lieu of degree.
• 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.

Responsibilities

• Author and revise Standard Operating Procedures (SOP), and associated documentation for cell therapy manufacturing in accordance with Current Good Manufacturing Practices (cGMP’s).
• Work closely with department SME’s 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.).

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level