Cell Therapy QC Specialist - Data & Validation

Biopharma Careers; Leiden; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

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

A strong background in cell therapy analytics and regulatory compliance is required. The position involves training teammates on QC methods such as flow cytometry, PCR, cell-based assays, and HPLC/UPLC,

Qualifications

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

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Troubleshoot and solve problems with minimal guidance.
• Review GMP documentation and data verification/review for methods.
• Manage document revisions, CAPA, deviations, and investigations to support continuous improvement.
• Mentor others on QC test methods (Flow cytometry, PCR, Cell-based assays, HPLC/UPLC).
• Perform other tasks as assigned.

Skills

Regulatory compliance

Technical writing

Problem solving

Communication

Teamwork

Education

Bachelor's degree in science

Tools

LIMS

ELN

Job description

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

A strong background in cell therapy analytics and regulatory compliance is required. The position involves training teammates on QC methods such as flow cytometry, PCR, cell-based assays, and HPLC/UPLC,