Cell Therapy Investigations Lead

Biopharma Careers; Harvard (MA); On-site; USD 83,000 - 100,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

Holidays and vacation

Job summary

Bristol Myers Squibb in Devens, MA seeks a Specialist, Investigations, Cell Therapy to lead deviation investigations in a cGMP manufacturing environment, drive CAPAs, and support continuous improvement. You will ensure thorough, scientifically sound investigations and compliant documentation.

This role collaborates with Manufacturing, QA, QC, and Engineering; requires a bachelor’s degree in science or related discipline and 1–3 years biopharma experience.

Qualifications

• Knowledge of deviation investigations and CAPA systems.
• Strong attention to detail and documentation.
• Ability to collaborate across Manufacturing, QA, QC, and Engineering.

Responsibilities

• Lead deviation investigations and CAPAs as a Primary Investigator.
• Draft investigation reports with clarity and regulatory compliance.
• Document activities in quality systems and verify CAPA effectiveness.
• Coordinate with multiple departments to support investigation efforts.
• Identify recurring issues and suggest process improvements.

Skills

Investigation processes

CAPA systems

Quality documentation

Cross-functional collaboration

Microsoft Office

Electronic quality systems

Education

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

Tools

Infinity

TrackWise

Veeva

Job description

Bristol Myers Squibb in Devens, MA seeks a Specialist, Investigations, Cell Therapy to lead deviation investigations in a cGMP manufacturing environment, drive CAPAs, and support continuous improvement. You will ensure thorough, scientifically sound investigations and compliant documentation.

This role collaborates with Manufacturing, QA, QC, and Engineering; requires a bachelor’s degree in science or related discipline and 1–3 years biopharma experience.