Cell Therapy QC Analytics Lead | Validation & Data Review

1010 Celgene - Summit (Corp); New Jersey; On-site; USD 56,000 - 68,000; Full time

Benefits offered by this job

Flexible Time Off

Paid holidays

Paid vacation

Volunteer days

Global Shutdown

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QC Analytical, Cell Therapy, to support QC testing across in-process, final product, and stability samples. You will review data, troubleshoot methods, train staff, and drive continuous improvement within a fast-paced environment.

The role reports to QC management and requires strong technical writing, GMP knowledge, and collaboration with cross-functional teams to ensure compliance and timely results in Summit West, NJ.

Qualifications

• Ability to accurately understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• 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.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Perform data verification, data review and review of GMP documentation for general and complex methods.
• Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods, processes and procedures.
• Perform other tasks as assigned.

Skills

Regulatory compliance

Technical writing

Problem solving

Cross-functional communication

Team performance

LIMS/ELN knowledge

Tools

LIMS

ELN

Job description

Bristol Myers Squibb is seeking a Senior Specialist, QC Analytical, Cell Therapy, to support QC testing across in-process, final product, and stability samples. You will review data, troubleshoot methods, train staff, and drive continuous improvement within a fast-paced environment.

The role reports to QC management and requires strong technical writing, GMP knowledge, and collaboration with cross-functional teams to ensure compliance and timely results in Summit West, NJ.