Senior QC Analyst, Cell Therapy

Bristol-Myers Squibb Co; Summit (NJ); On-site; USD 56,000 - 69,000; Full time

Benefits offered by this job

Benefits package

Flexible Time Off

11 paid holidays

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Senior Specialist, QC Analytical, Cell Therapy to support QC testing of in-process, final product, and stability samples. You will perform method transfer/validation, data review, deviations/investigations/CAPA, and drive continuous improvement efforts.

The role requires a Bachelor's degree (or equivalent) and 4+ years of analytical QC experience in a regulated environment, with experience in cell biology techniques such as flow cytometry and qPCR.

Qualifications

• Bachelor's degree or equivalent required, preferably in science. Netherlands: Bachelor's degree / HLO in (bioanalytical) science required.
• 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).

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 understanding

Technical writing

Problem solving

Communication skills

Time management

LIMS/ELN knowledge

Education

Bachelor's degree in science

Tools

LIMS

ELN

Job description

Bristol Myers Squibb in Summit, NJ is seeking a Senior Specialist, QC Analytical, Cell Therapy to support QC testing of in-process, final product, and stability samples. You will perform method transfer/validation, data review, deviations/investigations/CAPA, and drive continuous improvement efforts.

The role requires a Bachelor's degree (or equivalent) and 4+ years of analytical QC experience in a regulated environment, with experience in cell biology techniques such as flow cytometry and qPCR.