Senior QC Analytical Specialist, Cell Therapy

Bristol Myers Squibb; Denville (NJ); On-site; USD 56,000 - 68,000; Full time

Job summary

Bristol-Myers Squibb Co is seeking a Senior Specialist, QC Analytical, Cell Therapy to support in-process, final product, and stability testing in Summit West, NJ. You will perform method transfer/validation, data verification, and GMP documentation review to ensure quality and regulatory compliance.

The role requires strong technical writing, problem solving, and collaboration with cross-functional teams. Shift includes Sunday to Wednesday from 1:30pm to 11:30pm, with full-time hours and

Qualifications

• Understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• Strong problem-solving, analytical and logical thinking.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Troubleshoot and problem solve with minimal guidance.
• Perform data verification, data review and GMP documentation review.
• Perform document revision, project, CAPA and deviation/investigation tasks.
• Train and mentor others on QC test methods, processes and procedures.
• Perform other tasks as assigned.

Skills

Regulatory knowledge

cGMP compliance

Technical writing

Problem solving

Communication

Teamwork

LIMS/ELN

Tools

LIMS

ELN

Lab data systems

Job description

Bristol-Myers Squibb Co is seeking a Senior Specialist, QC Analytical, Cell Therapy to support in-process, final product, and stability testing in Summit West, NJ. You will perform method transfer/validation, data verification, and GMP documentation review to ensure quality and regulatory compliance.

The role requires strong technical writing, problem solving, and collaboration with cross-functional teams. Shift includes Sunday to Wednesday from 1:30pm to 11:30pm, with full-time hours and