Senior QC Analytical Scientist, Cell Therapy

Bristol Myers Squibb; United States; On-site; USD 125,000 - 151,000; Full time

Benefits offered by this job

Wellbeing support

Retirement plan

Insurance offerings

Job summary

Bristol Myers Squibb is seeking a Principal Scientist, QC Analytical, Cell Therapy to lead bioanalytical method transfer/validation and routine testing across in-process, final product, and stability samples. You will guide complex projects, CAPAs, deviations, and continuous improvement, interfacing with regulatory bodies and product-review processes.

The role requires deep knowledge of regulatory requirements, advanced technical writing, and the ability to work independently in a fast-paced

Qualifications

• Bachelor’s degree or equivalent in science; advanced degree preferred.
• 10+ years analytical testing experience; 2+ years QC.
• Expert knowledge of bioanalytical techniques incl. cell-based assays, ELISA, qPCR, flow cytometry.
• Regulatory and cGMP knowledge.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Lead method transfer/validation and routine testing of samples.
• Mentor and train QC team on complex methods and procedures.
• Develop, write, and execute methods, protocols, and reports per regulatory guidelines.
• Represent QC in product reviews and regulatory inspections; respond to regulatory requests.
• Review and approve lab investigations.
• Drive continuous improvement and CAPAs across QC.
• Coordinate cross-site collaboration for APQR ownership.

Skills

Regulatory knowledge

Technical writing

Problem solving

Independent work

Communication

Mentoring

Bioanalytical methods

QA/QC knowledge

Education

Bachelor’s degree in science

Advanced degree preferred

PhD in bioanalytical science (preferred)

Equivalent work experience considered

Job description

Bristol Myers Squibb is seeking a Principal Scientist, QC Analytical, Cell Therapy to lead bioanalytical method transfer/validation and routine testing across in-process, final product, and stability samples. You will guide complex projects, CAPAs, deviations, and continuous improvement, interfacing with regulatory bodies and product-review processes.

The role requires deep knowledge of regulatory requirements, advanced technical writing, and the ability to work independently in a fast-paced