QC Analytical Specialist — Cell Therapy Method Transfer

Bristol-Myers Squibb; Leiden; On-site; EUR 60,000 - 90,000; Full time

Job summary

Bristol Myers Squibb in Leiden seeks a Senior Specialist, QC Analytical to support in-process, final product, and stability testing, and to review GMP documentation. You will perform method transfer/validation, troubleshoot, and mentor others on QC methods.

Responsibilities include data verification, CAPA/investigation tasks, and continuous improvement efforts. The role requires two weekends per month and a strong foundation in bioanalytical science.

Qualifications

• Bachelor's degree or equivalent; Netherlands requirement for bioanalytical science.
• 4+ years in analytical testing or QC in a regulated environment.
• Experience with cell/molecular biology techniques and GMP documentation.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Troubleshoot problems with minimal guidance and perform data verification and GMP document reviews.
• Lead document revisions, project work, CAPA and deviation/investigation tasks; drive continuous improvement.
• Train and mentor others on QC test methods (Flow cytometry, PCR, cell-based assays, HPLC/UPLC).
• Perform other assigned tasks as needed.

Skills

Regulatory & cGMP knowledge

Technical writing

Problem solving

Communication

Team collaboration

LIMS/ELN familiarity

Education

Bachelor's degree (bioanalytical science preferred)

Netherlands: Bachelors/HLO in bioanalytical science required

Job description

Bristol Myers Squibb in Leiden seeks a Senior Specialist, QC Analytical to support in-process, final product, and stability testing, and to review GMP documentation. You will perform method transfer/validation, troubleshoot, and mentor others on QC methods.

Responsibilities include data verification, CAPA/investigation tasks, and continuous improvement efforts. The role requires two weekends per month and a strong foundation in bioanalytical science.