Senior Specialist, QC Analytical, Cell Therapy

Bristol Myers Squibb seeks a Senior Specialist in QC Analytical for cell therapy manufacturing at its Summit West, New Jersey facility. The role involves performing analytical testing, method validation, troubleshooting, and quality control documentation for in-process and final products on a Sunday-Wednesday evening shift.

Responsibilities

• Execute method transfer, validation, and routine testing of in-process, final product, and stability samples
• Perform data verification, review GMP documentation, and troubleshoot analytical methods
• Lead document revisions, projects, deviations, investigations, and continuous improvement initiatives
• Train and mentor laboratory staff on QC test methods and procedures
• Support problem-solving and process optimization with minimal guidance

Requirements

• Bachelor's degree in science or equivalent
• 4+ years analytical testing or QC experience in regulated environment
• Demonstrated cell and molecular biology techniques experience (cell-based assays, flow cytometry, qPCR, ELISA, aseptic technique)
• Strong understanding of cGMP and regulatory requirements
• Technical writing and effective cross-functional communication skills
• Advanced LIMS, ELN and laboratory data analysis system knowledge preferred

Compensation: $40.97 - $49.64 per hour