QC Analyst I/II
Legend Biotech
September 02, 2026
On-site
Raritan, NJ
Operations
QC Analyst (Quality Operations) — Raritan, NJ
Role Overview
Exempt position performing QC testing for manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Responsibilities
- Complete QC testing for autologous CAR-T products in a controlled cGMP cleanroom.
- Ensure testing complies with applicable procedures, standards, and GMP regulations.
- Perform analytical testing of raw material/utility, in-process, or final product samples.
- Conduct peer review/approval of laboratory data.
- Use LIMS to execute and document testing.
- Create, review, and approve relevant QC documents, SOPs, and WI’s.
- Follow safety policies, quality systems, and cGMP requirements; collaborate with QA, Manufacturing Operations, and Analytical/Process Development.
Requirements
- Bachelor’s degree in Science, Engineering, or equivalent technical discipline (required).
- 1+ year relevant experience, preferably in biological and/or pharmaceutical industry (required).
- Quality Control experience (preferred).
- Biosafety cabinet sample processing with aseptic technique (strongly preferred).
- cGMP regulations and FDA/EU guidance for cell-based products (strongly preferred).
- Good Tissue Practices (required).
- CAR-T QC test methods/equipment (preferred).
- Excellent written and oral communication (required).
- Shift work (weekends/evenings) and unplanned overtime (nights/weekends) as needed.
- Able to speak with regulatory inspectors; occasional travel (up to 5%).
Benefits (per job description)
Medical/dental/vision; 401(k) match (day one); 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays); additional voluntary benefits (e.g., FSA/HSA, life/AD&D, disability, legal assistance, supplemental insurance).
Role Overview
Exempt position performing QC testing for manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Responsibilities
- Complete QC testing for autologous CAR-T products in a controlled cGMP cleanroom.
- Ensure testing complies with applicable procedures, standards, and GMP regulations.
- Perform analytical testing of raw material/utility, in-process, or final product samples.
- Conduct peer review/approval of laboratory data.
- Use LIMS to execute and document testing.
- Create, review, and approve relevant QC documents, SOPs, and WI’s.
- Follow safety policies, quality systems, and cGMP requirements; collaborate with QA, Manufacturing Operations, and Analytical/Process Development.
Requirements
- Bachelor’s degree in Science, Engineering, or equivalent technical discipline (required).
- 1+ year relevant experience, preferably in biological and/or pharmaceutical industry (required).
- Quality Control experience (preferred).
- Biosafety cabinet sample processing with aseptic technique (strongly preferred).
- cGMP regulations and FDA/EU guidance for cell-based products (strongly preferred).
- Good Tissue Practices (required).
- CAR-T QC test methods/equipment (preferred).
- Excellent written and oral communication (required).
- Shift work (weekends/evenings) and unplanned overtime (nights/weekends) as needed.
- Able to speak with regulatory inspectors; occasional travel (up to 5%).
Benefits (per job description)
Medical/dental/vision; 401(k) match (day one); 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays); additional voluntary benefits (e.g., FSA/HSA, life/AD&D, disability, legal assistance, supplemental insurance).