Bristol-Myers Squibb - Summit, NJ

posted 10 days ago

Full-time - Mid Level
Hybrid - Summit, NJ
Chemical Manufacturing

About the position

The Scientist position in QC Analytical for Cell Therapy at Bristol Myers Squibb is responsible for supporting routine testing of samples in the Quality Control lab of the CAR T Manufacturing facility. This role involves acting as a subject matter expert for commercial methods, troubleshooting, and training, while ensuring compliance with BMS policies and global regulatory requirements. The position offers an opportunity to contribute to meaningful work that transforms patient lives through innovative cell therapy solutions.

Responsibilities

  • Support method transfer/validation and routine testing of in-process, final product, and stability samples.
  • Review testing data including data packets, final lot files, and Certificates of Analysis (COA).
  • Anticipate and perform complex troubleshooting and problem solving independently.
  • Perform data verification, data review, and review of GMP documentation for multiple methods and products.
  • Own project, CAPA, and deviation/investigation related tasks and continuous improvement efforts.
  • Represent the department in regulatory inspections and internal/external audits.
  • Train and mentor others on multiple QC test methods, processes, and procedures.
  • Cross-train on multiple complex analytical methods and/or products.
  • Author and review/revise technical documents such as test methods, SOPs, specifications, and trend reports.

Requirements

  • Bachelor's degree or equivalent in science, or an equivalent combination of education and experience in a regulated environment.
  • 6+ years of relevant analytical testing or QC experience.
  • Demonstrated experience in cell and molecular biology techniques such as cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique.
  • Ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
  • Demonstrated technical writing skills and high problem-solving ability.
  • Ability to communicate effectively with peers and management.
  • Advanced knowledge of LIMS, ELN, and laboratory data analysis systems preferred.

Nice-to-haves

  • Experience in a regulated environment.
  • Strong mentoring, coaching, influencing, negotiating, and personnel interaction skills.

Benefits

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Work-life balance and flexibility in the work environment.
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