QC Analytical Specialist: Transfer & Validation (Hybrid)

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

Job summary

Bristol Myers Squibb in Leiden is seeking a Senior Specialist QC Analytical to perform method transfer/validation and routine testing across in-process, final product, and stability samples.

You will train new analysts, verify data, review GMP documentation, and support investigations and CAPA initiatives in a fast-paced, cross-functional QC team.

The role requires strong knowledge of LIMS, quality systems, and regulatory expectations, with 4+ years of relevant analytical experience.

Qualifications

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• 4+ years of relevant analytical testing or QC experience in a regulated environment.
• Experience with cell and molecular biology techniques (HPLC/UPLC, flow cytometry, qPCR, ELISA) and aseptic technique.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Troubleshoot and solve problems with minimal guidance.
• Perform data verification, data review, and GMP documentation review for general and complex methods.
• Complete document revisions, CAPA and deviation/investigation tasks and continuous improvement.
• Train and mentor others on QC methods and GMP processes.
• Support other QC lab tasks as required.

Skills

Regulatory compliance

Technical writing

Cross-functional teamwork

Communication

Problem solving

Education

Bachelor's or higher in science

Master’s in bioanalytical science (NL)

Tools

LIMS

Document Management

Quality Management Systems

Job description

Bristol Myers Squibb in Leiden is seeking a Senior Specialist QC Analytical to perform method transfer/validation and routine testing across in-process, final product, and stability samples.

You will train new analysts, verify data, review GMP documentation, and support investigations and CAPA initiatives in a fast-paced, cross-functional QC team.

The role requires strong knowledge of LIMS, quality systems, and regulatory expectations, with 4+ years of relevant analytical experience.