QC Analyst for CAR-T Cell Therapy (GMP)

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

Benefits offered by this job

Medical/dental/vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech seeks a QC Analyst for the Quality Operations team based in Raritan, NJ. This role focuses on QC testing of autologous CAR‑T products for clinical trials and commercial manufacturing in a controlled cGMP cleanroom.

The ideal candidate has a science/engineering background with 1+ year of QC experience and strong aseptic technique. The position involves shift work, potential overtime, and collaboration with QA, Manufacturing, and Development teams.

Qualifications

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• 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.
• Knowledge of CAR‑T QC test methods and related equipment is preferred.
• Excellent written and oral communication skill are required.
• Candidates must be able to accommodate shift schedule, including weekends and evenings as needed.
• Willingness for occasional travel and overtime as business demands.

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, SOPs and WI’s.
• Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
• Work collaboratively with Quality Assurance, Manufacturing Operations, and Analytical/Process Development.

Skills

Quality control

GMP knowledge

Aseptic technique

LIMS familiarity

Analytical testing

Education

Bachelor’s degree in Science/Engineering

Tools

LIMS

Job description

Legend Biotech seeks a QC Analyst for the Quality Operations team based in Raritan, NJ. This role focuses on QC testing of autologous CAR‑T products for clinical trials and commercial manufacturing in a controlled cGMP cleanroom.

The ideal candidate has a science/engineering background with 1+ year of QC experience and strong aseptic technique. The position involves shift work, potential overtime, and collaboration with QA, Manufacturing, and Development teams.