Cell Therapy QC Analyst I/II – cGMP Testing Specialist

Legend Biotech USA; Raritan (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Legend Biotech in Raritan, NJ is seeking a QC Analyst to join the Quality Operations team. The exempt role performs QC testing for autologous CAR-T product manufacturing in a controlled cGMP environment, supporting clinical trials and commercial operations.

You will execute testing, review data, use LIMS, prepare and approve QC documents, and collaborate with QA, Manufacturing, and Analytical Development. This role involves handling biological materials, safety protocols, and occasional travel

Qualifications

• Bachelor's degree in science, engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably in biology/pharmaceutical industry.
• Experience in a QC testing environment preferred.
• Experience with aseptic technique in biosafety cabinets is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Excellent written and oral communication skills are required.

Responsibilities

• Complete QC testing related to manufacturing of autologous CAR-T products for clinical trials and commercial operation.
• Ensure testing is completed in compliance with procedures, standards and GMP regulations.
• Conduct analytical testing of raw material, in-process, or final product samples.
• Perform peer review/approval of laboratory data.
• Utilize LIMS for execution and documentation of testing.
• Create, review and approve QC documents, SOPs and WI's.
• Work safely and in accordance with quality systems and cGMP requirements.
• Collaborate with QA, Manufacturing Operations, and Analytical/Process Development.
• Be prepared for exposure to biological materials and hazardous chemicals.

Skills

LIMS experience

Analytical testing

Communication skills

cGMP knowledge

CAR-T QC knowledge

Education

Bachelor's Degree in Science, Engineering or equivalent technical discipline

Job description

Legend Biotech in Raritan, NJ is seeking a QC Analyst to join the Quality Operations team. The exempt role performs QC testing for autologous CAR-T product manufacturing in a controlled cGMP environment, supporting clinical trials and commercial operations.

You will execute testing, review data, use LIMS, prepare and approve QC documents, and collaborate with QA, Manufacturing, and Analytical Development. This role involves handling biological materials, safety protocols, and occasional travel