Specialist, Investigations, Cell Therapy

Bristol Myers Squibb•Devens, MA

5d•Onsite

About The Position

The Specialist, Investigations, Cell Therapy leads and supports deviation investigations within a cGMP-compliant cell therapy manufacturing environment. The role ensures investigations are timely, thorough, and scientifically sound, and that they result in effective corrective and preventive actions (CAPAs), supporting continuous improvement and compliance with regulatory expectations. The position is based in Devens, Massachusetts, and has a Monday–Friday schedule from 8 a.m. to 5 p.m. It reports to the Senior Manager, Investigations, Cell Therapy, within the site Manufacturing Science & Technology department. Work is performed in an office environment, with approximately 15% of the time potentially spent in a clean-room manufacturing environment. The role requires knowledge generally attained through a bachelor’s degree in science, engineering, biochemistry, or a related discipline, plus 1–3 years of experience in biopharmaceutical operations or equivalent experience. Compensation is listed at $82,700–$100,219. Additional discretionary incentive cash and stock opportunities may be available. Benefits may include wellbeing support, retirement and financial protection benefits, medical, dental, vision, life and disability insurance, paid time off, company holidays, and other time-off benefits, subject to eligibility and plan terms.

Requirements

Bachelor’s degree in science, engineering, biochemistry, or a related discipline, or equivalent.
1–3 years of experience in biopharmaceutical operations, or equivalent experience.
Familiarity with investigation processes, CAPA systems, and quality documentation.
Strong attention to detail and organizational skills, with the ability to manage multiple priorities.
Effective communication and interpersonal skills for collaborative work across teams.
Understanding of Quality Risk Management and Operational Excellence principles.

Nice To Haves

Proficiency in Microsoft Office.
Experience with electronic quality systems such as Infinity, TrackWise, or Veeva.

Responsibilities

Conduct and manage 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.
Document investigation activities accurately and in a timely manner in compliance with cGMP and internal procedures.
Coordinate investigation activities with Manufacturing, Quality Assurance, Quality Control, Engineering, and other departments.
Track and support CAPA implementation, including scheduling, documentation, and verification of effectiveness.
Identify recurring issues and contribute ideas for process enhancements as part of continuous improvement initiatives.
Maintain current knowledge of investigation procedures, regulatory expectations, and quality systems through ongoing training and development.

Benefits

Wellbeing support.
Retirement and financial protection benefits.
Medical, dental, vision, life, and disability insurance offerings.
Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico, subject to manager approval.
11 paid company holidays annually.
Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
Depending on eligibility, 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 may receive an annual Global Shutdown between Christmas Day and New Year's Day.
May be eligible for additional discretionary incentive cash and stock opportunities.