Sr. QC Analyst

Responsibilities

• Complete QC testing for autologous CAR-T products in a cGMP cleanroom environment
• Conduct analytical testing of raw materials, utilities, in-process, and final product samples
• Perform peer review and approval of laboratory data
• Utilize LIMS for execution and documentation of testing
• Create, review, and approve QC documents, SOPs, and WIs
• Collaborate with Quality Assurance, Manufacturing Operations, and Analytical/Process Development teams

Requirements

• Bachelor’s Degree in Science, Engineering, or equivalent technical discipline
• Minimum of 1 year relevant work experience, preferably in biological or pharmaceutical industry
• Knowledge of Good Tissue Practices
• Excellent written and oral communication skills
• Ability to work 3rd shift (Wed-Sat) and accommodate unplanned overtime including nights and weekends
• Ability to handle biological materials and hazardous chemicals

Preferred Qualifications

• Experience in a Quality Control setting
• Experience with aseptic technique in biosafety cabinets
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products
• Knowledge of CAR-T QC test methods and related equipment

About the Company

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases through advanced cell therapies, including CAR-T, TCR-T, and NK cell-based immunotherapies.