Specialist, Investigations, Cell Therapy in Devens, MA

Bristol-Myers Squibb • Devens, MA

102d • $79,150 - $95,914 • Hybrid

About The Position

The Specialist, Investigations, Cell Therapy is responsible for leading and supporting deviation investigations within a cGMP-compliant cell therapy manufacturing environment. This role ensures timely, thorough, and scientifically sound investigations that drive effective corrective and preventive actions (CAPAs), contributing to continuous improvement and compliance with regulatory expectations.

Requirements

• Knowledge of science generally attained through studies resulting in a bachelor's degree in science, engineering, biochemistry or related discipline plus 1-3 years' experience in biopharmaceutical operations, or its equivalent is required.
• Familiarity with investigation processes, CAPA systems, and quality documentation.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective communication and interpersonal skills to work collaboratively across teams.
• Proficiency in Microsoft Office and experience with electronic quality systems (e.g., Infinity, TrackWise, Veeva) is a plus.
• Understanding of Quality Risk Management and Operational Excellence principles.

Responsibilities

• Conduct and manage the resolution of root cause investigations, including impact assessments, and CAPAs as a Lead Investigator
• Draft investigation reports and CAPAs, ensuring clarity, accuracy, and compliance with internal procedures.
• Ensure accurate and timely documentation of investigation activities in compliance with cGMP and internal procedures.
• Coordinate with Manufacturing, Quality Assurance, Quality Control, Engineering, and other departments to support investigation activities.
• Track and support the implementation of CAPAs, including scheduling, documentation, and verification of effectiveness.
• Participate in continuous improvement initiatives by identifying recurring issues and contributing ideas for process enhancements.
• Stay current with investigation procedures, regulatory expectations, and quality systems through ongoing training and development.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree