Senior QC Analytical Specialist – Cell Therapy

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 56,000 - 69,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QC Analytical, Cell Therapy to support QC testing of in-process, final product and stability samples, and to review data and GMP documentation. The role includes method troubleshooting, transfer/validation, and driving continuous improvement.

In Summit West, NJ, the position follows a Sunday-Wednesday night shift (1:30pm-11:30pm) with opportunities to mentor colleagues and contribute to documentation, CAPA, and deviations in a fast-paced GMP

Qualifications

• Bachelor's degree or equivalent in science; Netherlands-specific note mentioned in posting.
• 4+ years of analytical testing or QC in a regulated environment.
• Experience with cell and molecular biology techniques (cell-based assays, flow cytometry, qPCR, ELISA).

Responsibilities

• Perform method transfer/validation and routine testing of samples.
• Troubleshoot problems with minimal guidance.
• Review data and GMP documentation for methods.
• Manage document revisions, CAPA, deviations/investigations.
• Train/mentor others on QC test methods and processes.
• Perform additional tasks as assigned.

Skills

Regulatory & cGMP knowledge

Technical writing

Problem solving

Cross-functional communication

Team environment

LIMS/ELN proficiency

Education

Bachelor's degree in science

4+ years QC/analytical testing

Cell/molecular biology techniques

Tools

LIMS

ELN

Laboratory data analysis software

Job description

Bristol Myers Squibb is seeking a Senior Specialist, QC Analytical, Cell Therapy to support QC testing of in-process, final product and stability samples, and to review data and GMP documentation. The role includes method troubleshooting, transfer/validation, and driving continuous improvement.

In Summit West, NJ, the position follows a Sunday-Wednesday night shift (1:30pm-11:30pm) with opportunities to mentor colleagues and contribute to documentation, CAPA, and deviations in a fast-paced GMP