Cell Therapy QC Analyst – Impactful, Data-Driven Role

Bristol Myers Squibb; Denville (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 West, NJ. The role supports in-process, final product, and stability testing and assists with data review and GMP documentation.

The position operates Wed–Sat, 1:30pm–11:30pm, within a collaborative, regulated environment. You will contribute to method transfer, deviations, and continuous improvement while working with cross-functional teams to ensure adherence to global regulatory and cGMP requirements.

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/ELN familiarity

Problem-solving

Effective communication

Technical documentation

Team-oriented

Education

Bachelor's degree in science

2+ years QC/testing experience

Cell/molecular biology techniques

Tools

Flow cytometry

qPCR

ELISA

Aseptic technique

Cell-based assays

Job description

Bristol Myers Squibb is seeking a Specialist, QC Analytical, Cell Therapy in Summit West, NJ. The role supports in-process, final product, and stability testing and assists with data review and GMP documentation.

The position operates Wed–Sat, 1:30pm–11:30pm, within a collaborative, regulated environment. You will contribute to method transfer, deviations, and continuous improvement while working with cross-functional teams to ensure adherence to global regulatory and cGMP requirements.