Cell Therapy QC Analyst — In-Process & Final Product

Bristol Myers Squibb; Summit (NJ); On-site; USD 48,000 - 58,000; Full time

Job summary

Bristol Myers Squibb is seeking a Specialist, QC Analytical, Cell Therapy in Summit, NJ to support in-process, final product, and stability testing. The role involves data review, method transfer tasks, deviations, and continuous improvement within a regulated environment.

The candidate will train analysts, review GMP documentation, and ensure adherence to global regulatory standards and cGMP requirements. Strong technical writing and collaboration with cross-functional teams are essential.

Qualifications

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Experience with writing technical documents preferred.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Perform testing for method transfer/validation/verification.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Skills

cGMP knowledge

LIMS experience

ELN experience

Data verification

Communication skills

Education

Bachelor's degree in science

Tools

LIMS

ELN

Flow cytometry

Job description

Bristol Myers Squibb is seeking a Specialist, QC Analytical, Cell Therapy in Summit, NJ to support in-process, final product, and stability testing. The role involves data review, method transfer tasks, deviations, and continuous improvement within a regulated environment.

The candidate will train analysts, review GMP documentation, and ensure adherence to global regulatory standards and cGMP requirements. Strong technical writing and collaboration with cross-functional teams are essential.