Specialist, Investigations, Cell Therapy

0545 Devens; Harvard (MA); On-site; USD 83,000 - 100,000; Full time

Job summary

Bristol Myers Squibb is seeking a Specialist, Investigations, Cell Therapy in Devens, MA to lead deviation investigations within a cGMP cell therapy manufacturing environment. The role ensures timely, thorough investigations that drive CAPAs, contribute to continuous improvement, and ensure regulatory compliance.

You will collaborate with Manufacturing, QA, QC, and Engineering teams to support investigation activities.

Qualifications

• Knowledge of investigation processes and CAPA systems.
• Experience with quality documentation and records management.
• Strong attention to detail and ability to handle multiple priorities.
• Effective communication to collaborate across teams.
• Familiarity with MS Office and electronic quality systems (Infinity, TrackWise, Veeva) is a plus.
• Understanding of Quality Risk Management and Operational Excellence.

Responsibilities

• Lead and manage root cause investigations and CAPAs as a Lead Investigator.
• Draft investigation reports with clarity and accuracy.
• Document investigation activities in compliance with cGMP and procedures.
• Coordinate with Manufacturing, QA, QC, Engineering to support investigations.
• Track CAPA implementation, scheduling and verification of effectiveness.
• Identify recurring issues and contribute process improvement ideas.
• Stay current with investigation procedures and regulatory expectations through training.

Skills

Investigation processes

CAPA systems

Quality documentation

Attention to detail

Cross-team communication

MS Office

Electronic quality systems

Quality Risk Management

Education

Bachelor's degree in science/engineering

Tools

Infinity

TrackWise

Veeva

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?" - a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. 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.

Position Summary

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.

Shifts Available

Monday - Friday, 8am - 5pm

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.

Knowledge & Skills

• 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.

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.

Working Conditions

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

Compensation Overview

Devens - MA - US: $82,700 - $100,219

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. To check your application status, please login to your Candidate Home Account.

R1607945 : Specialist, Investigations, Cell Therapy Data Privacy Link

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.