Cell Therapy Investigations Specialist

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

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

Vacation for new hires

Job summary

Bristol Myers Squibb is seeking a Specialist, Investigations, Cell Therapy to lead and support deviation investigations within a cGMP‑compliant cell therapy manufacturing environment.

You will draft investigation reports, manage CAPAs, ensure documentation, and collaborate with Manufacturing, QA, QC, Engineering to drive continuous improvement and regulatory alignment. Shifts: Monday–Friday, 8am–5pm.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline with 1–3 years biopharmaceutical ops experience.
• Familiarity with CAPA systems and quality documentation.
• Experience documenting investigations in a cGMP environment with attention to detail.
• Proficiency in Microsoft Office and familiarity with electronic QA systems (Infinity, TrackWise, Veeva).

Responsibilities

• Conduct and manage root cause investigations, including impact assessments and CAPAs as a Lead Investigator.
• Draft investigation reports and CAPAs with clear, accurate documentation.
• Ensure timely documentation of investigation activities per cGMP and procedures.
• Coordinate with Manufacturing, QA, QC, Engineering and other departments to support investigations.
• Track and support CAPA implementation including scheduling, documentation, and effectiveness verification.
• Participate in continuous improvement by identifying recurring issues and proposing process enhancements.
• Stay current with investigation procedures, regulatory expectations, and quality systems through ongoing training.

Skills

Investigation processes

CAPA systems

Attention to detail

Communication skills

Microsoft Office

Electronic quality systems

Infinity

TrackWise

Veeva

Quality Risk Management

Operational Excellence

Education

Bachelor's degree in science, engineering, biochemistry or related discipline

Tools

Infinity

TrackWise

Veeva

Job description

Bristol Myers Squibb is seeking a Specialist, Investigations, Cell Therapy to lead and support deviation investigations within a cGMP‑compliant cell therapy manufacturing environment.

You will draft investigation reports, manage CAPAs, ensure documentation, and collaborate with Manufacturing, QA, QC, Engineering to drive continuous improvement and regulatory alignment. Shifts: Monday–Friday, 8am–5pm.