QC Analyst I/II, CAR-T Cell Therapy QC (GMP)

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

Legend Biotech is seeking a QC Analyst to join the Quality Operations team in Raritan, NJ. The role focuses on QC testing for manufacturing autologous CAR-T products in a controlled cGMP environment.

The candidate will use LIMS for documentation, review data, and contribute to SOPs and WI’s, while ensuring compliance with GMP and regulatory requirements. This exempt role requires flexibility for shift work 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 biological/pharmaceutical industries.
• Experience in a Quality Control setting is preferred.
• 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.

Responsibilities

• Complete QC testing related to manufacturing of autologous CAR-T products for clinical trials and commercial operations.
• Ensure testing complies with procedures, standards, and GMP regulations.
• Conduct analytical testing of raw materials, 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 in alignment with policies and cGMP requirements.
• Collaborate with QA, Manufacturing Operations, and Analytical/Process Development.

Skills

Excellent communication

Team collaboration

Attention to detail

Shift flexibility

Education

Bachelor’s degree in Science or Engineering

Tools

LIMS

Job description

Legend Biotech is seeking a QC Analyst to join the Quality Operations team in Raritan, NJ. The role focuses on QC testing for manufacturing autologous CAR-T products in a controlled cGMP environment.

The candidate will use LIMS for documentation, review data, and contribute to SOPs and WI’s, while ensuring compliance with GMP and regulatory requirements. This exempt role requires flexibility for shift work and occasional travel.