Senior Specialist, QC Analytical

Senior Specialist, QC Analytical position at Bristol Myers Squibb's CAR T manufacturing facility in Summit, NJ. Responsible for performing analytical testing of in-process, final product, and stability samples while supporting data review and regulatory compliance in a fast-paced quality control environment.

Responsibilities

• Perform method transfer, validation, and routine testing of in-process, final product, and stability samples
• Execute troubleshooting and problem-solving activities independently with minimal direction
• Conduct data verification, review, and GMP documentation assessment for general and complex methods
• Support document revisions, CAPAs, deviations, investigations, and continuous improvement initiatives
• Train and mentor colleagues on QC test methods, processes, and laboratory procedures

Requirements

• Bachelor's degree in Science or equivalent; advanced degree preferred
• 4+ years of analytical testing or QC experience in regulated environment
• Demonstrated expertise in cell and molecular biology techniques (flow cytometry, qPCR, ELISA, cell-based assays, aseptic technique)
• Strong technical writing and data analysis skills
• High problem-solving ability with minimal guidance required
• Advanced knowledge of LIMS, ELN, and laboratory data systems preferred

Compensation: $40.97 - $49.64 per hour