QC Analyst - Cell Therapy GMP Lab (CAR-T)

Legend Biotech; Raritan (NJ); On-site; USD 68,000 - 89,000; Full time

Benefits offered by this job

Medical insurance

401(k) match

Parental leave

Paid time off

Job summary

Legend Biotech in Bridgewater, New Jersey, is seeking a QC Analyst to join the Quality Operations team in a controlled GMP environment. The role focuses on QC testing of autologous CAR‑T products for clinical trials and commercial operations, ensuring compliance with procedures, standards and GMP regulations.

You will perform analytical testing, review data, use LIMS, and collaborate across QA, Manufacturing Operations, and Analytical Development.

Qualifications

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry.
• Experience in a Quality Control setting is preferred.
• Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.

Responsibilities

• Be responsible for the completion of QC testing related to the manufacturing of autologous CAR‑T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
• Conduct analytical testing of raw material/utility, in‑process, or final product samples submitted to the QC laboratories.
• Perform peer review/approval of laboratory data.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
• Job duties performed require routine exposure to and handling of biological materials and hazardous chemicals.

Skills

QC testing

cGMP knowledge

Analytical skills

Communication skills

Education

Bachelor’s Degree in Science/Engineering

Tools

LIMS

Biosafety Cabinets

GMP documentation

Job description

Legend Biotech in Bridgewater, New Jersey, is seeking a QC Analyst to join the Quality Operations team in a controlled GMP environment. The role focuses on QC testing of autologous CAR‑T products for clinical trials and commercial operations, ensuring compliance with procedures, standards and GMP regulations.

You will perform analytical testing, review data, use LIMS, and collaborate across QA, Manufacturing Operations, and Analytical Development.