Senior Specialist, Investigations, Cell Therapy - Devens, MA

This role is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

About the role

At Bristol Myers Squibb, we offer uniquely interesting work that transforms the lives of patients and the careers of those who do it. You’ll grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. We recognize the importance of balance and flexibility, providing a wide variety of competitive benefits, services, and programs to support both professional and personal goals.

As part of our Cell Therapy team, you will help reimagine the future of cell therapy, unlocking its full promise to put more patients on the path to a cure. The Senior Specialist, Investigations, Cell Therapy provides investigation leadership at the Devens Cell Therapy Facility, performing root cause analysis, collaborating with stakeholders, and facilitating impact assessments.

Responsibilities

• Conduct and manage the resolution of root cause investigations, including impact assessments and CAPAs as a Lead Investigator.
• Collaborate with multiple groups/organizations as a Lead Investigator, including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control.
• Proactively manage the progression of investigations and CAPAs to timely and compliant closure per established KPIs.
• Present investigation findings to key stakeholders and site senior management.
• Use Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste.
• Ensure safe and compliant cGMP operations and maintain permanent inspection readiness; actively support regulatory inspections.

Requirements

• Bachelor’s degree in science, engineering, biochemistry, or a related discipline plus 2-4 years’ experience in biopharmaceutical operations, or its equivalent.
• Experience utilizing root cause analysis/OPEX tools and identifying corrective and preventative actions preferred.
• Experience with Operational Excellence and Lean Manufacturing is a plus.
• Experience in cell therapy, biologics, or vaccine manufacturing/support desired.
• Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations desired.
• Excellent verbal/written communication skills and ability to influence at all levels.
• Ability to think strategically and translate strategy into action.
• Ability to prioritize and provide clear direction in a highly dynamic environment.

Working Conditions

• Position may require working in a Clean-Room manufacturing environment approximately 15% of the time.
• Remainder of work is performed in an office environment.

Schedule

Monday – Friday, 8am – 5pm

Pay

Devens, MA: $88,190 - $106,863 (full-time). Additional incentive cash and stock opportunities may be available based on eligibility. The starting pay rate reflects required skills, location, work schedule, job-related knowledge, and experience. Final compensation will be decided based on demonstrated experience.