QC Analyst, Cell Therapy (CAR-T) – GMP

Socket.dev; Raritan (NJ); On-site; USD 68,000 - 89,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech is seeking a QC Analyst to join the Quality Operations team in Raritan, NJ. The role involves performing QC testing for cell therapy products used in clinical trials and commercial operations within a controlled cGMP cleanroom.

The candidate will ensure compliance with procedures and GMP regulations, perform data review, and use LIMS for documentation. Travel to NJ/PA partner sites may be required.

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.
• 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.
• Excellent written and oral communication skill are 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 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.

Skills

Attention to detail

Written and verbal communication

Team collaboration

Regulatory compliance

Problem solving

Education

Bachelor’s degree in Science/Engineering

Tools

LIMS

Job description

Legend Biotech is seeking a QC Analyst to join the Quality Operations team in Raritan, NJ. The role involves performing QC testing for cell therapy products used in clinical trials and commercial operations within a controlled cGMP cleanroom.

The candidate will ensure compliance with procedures and GMP regulations, perform data review, and use LIMS for documentation. Travel to NJ/PA partner sites may be required.