QC Analyst

Legend Biotech is seeking QC Analyst as part of the Quality team based in Raritan, NJ. 

Role Overview

The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key 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
• Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products
• 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 the safety policies, quality systems and cGMP requirements

Requirements

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required
• Minimum of 1 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required
• Experience in a Quality Control setting is preferred
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required
• Knowledge of Good Tissue Practices is required
• Detailed 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. Shifts include routine weekend and evening work as required by the manufacturing process
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision
• Comfortable with speaking and interacting with inspectors
• This position may require occasional travel to partner sites in NJ or PA as business demands
• This position may require up to 10% domestic or international travel as business demands

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