Lead Bioanalytical Scientist – QC & Cell Therapy

Bristol Myers Squibb EU Policy; Harvard (MA); On-site; USD 125,000 - 151,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Health benefits

Job summary

Bristol Myers Squibb Devens, MA is seeking a Senior Scientist for QC Analytical to lead bioanalytical method transfer, validation, and routine testing across in-process and final products. This role requires deep regulatory knowledge, advanced writing skills, and the ability to drive CAPAs and continuous improvement.

The candidate will mentor staff, develop methods and protocols, and represent QC in product reviews and regulatory inspections, ensuring alignment with global regulations and cGMP

Qualifications

• Bachelor’s degree in science required; advanced degree preferred.
• 10+ years in analytical testing with 2+ years QC experience.
• Expert knowledge of cell-based assays, ELISA, qPCR, flow cytometry and method transfer.
• Ability to lead CAPAs, deviations and continuous improvement.

Responsibilities

• Lead method transfer/validation and routine testing of in-process, final product, and stability samples.
• Mentor team on QC methods and procedures.
• Prepare documents aligned with regulatory guidelines and corporate policies.
• Represent the department in product review boards and regulatory inspections; author responses.
• Review and approve laboratory investigations.
• Foster a positive quality culture and cross-functional collaboration.
• Own sections of APQR and communicate across sites.

Skills

Regulatory compliance

Technical writing

Analytical testing

Bioanalytical techniques

Education

Bachelor's degree in science

Advanced degree preferred

PhD in bioanalytical science (Netherlands) preferred

Job description

Bristol Myers Squibb Devens, MA is seeking a Senior Scientist for QC Analytical to lead bioanalytical method transfer, validation, and routine testing across in-process and final products. This role requires deep regulatory knowledge, advanced writing skills, and the ability to drive CAPAs and continuous improvement.

The candidate will mentor staff, develop methods and protocols, and represent QC in product reviews and regulatory inspections, ensuring alignment with global regulations and cGMP