Cell Therapy Investigations Lead

Bristol-Myers Squibb Co; Harvard (MA); On-site; USD 83,000 - 100,000; Full time

Job summary

Bristol Myers Squibb is seeking a Specialist, Investigations, Cell Therapy at the Devens, MA site. You will lead and support deviation investigations in a cGMP cell therapy environment, driving CAPAs and continuous improvement.

Requires a bachelor’s degree in science, engineering, biochemistry or related discipline and 1–3 years in biopharmaceutical operations. Strong knowledge of CAPA systems, quality documentation, and cross‑functional collaboration is essential.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry, or related discipline required.
• 1–3 years’ experience in biopharmaceutical operations.
• Knowledge of investigation processes, CAPA, and quality documentation.
• Proficiency in Microsoft Office; experience with electronic quality systems (Infinity, TrackWise, Veeva) is a plus.

Responsibilities

• Conduct and manage root-cause investigations, including impact assessments and CAPAs.
• Draft investigation reports and CAPAs with clarity, accuracy, and compliance.
• Ensure documentation of investigation activities follows cGMP and internal procedures.
• Coordinate with Manufacturing, QA, QC, Engineering, and other departments to support investigations.
• Track and support CAPA implementation, including scheduling, documentation, and verification of effectiveness.
• Participate in continuous improvement by identifying recurring issues and suggesting process enhancements.
• Stay current with investigation procedures and regulatory expectations.

Skills

Investigation processes

CAPA systems

Quality documentation

Cross-functional collaboration

MS Office

Quality Systems

Regulatory compliance

Education

Bachelor's degree in science/engineering/biochemistry

Tools

Infinity

TrackWise

Veeva

Job description

Bristol Myers Squibb is seeking a Specialist, Investigations, Cell Therapy at the Devens, MA site. You will lead and support deviation investigations in a cGMP cell therapy environment, driving CAPAs and continuous improvement.

Requires a bachelor’s degree in science, engineering, biochemistry or related discipline and 1–3 years in biopharmaceutical operations. Strong knowledge of CAPA systems, quality documentation, and cross‑functional collaboration is essential.