QC Analyst I

Legend Biotech - Raritan, NJ

Full-time - Entry Level

Raritan, NJ

Professional, Scientific, and Technical Services

About the position

Legend Biotech is seeking a QC Analyst as part of the Quality team based in Raritan, NJ. The QC Analyst, CAR-T Manufacturing is an exempt level position responsible for performing quality control (QC) testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled Good Manufacturing Practice (GMP) environment. This role is critical in ensuring that all products meet the required quality standards before they are released for clinical use or commercial distribution. In this position, the QC Analyst will be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products. This includes ensuring that all testing is completed in compliance with applicable procedures, standards, and GMP regulations. The QC Analyst will work closely with the Process Development team, Quality, and Operations organization to successfully transfer process and analytical testing to the cGMP facility for product manufacturing. The role also involves conducting analytical testing of raw materials, in-process samples, and final product samples submitted to the QC laboratories. The QC Analyst will perform peer review and approval of laboratory data, utilize electronic systems such as Laboratory Information Management Systems (LIMS) for the execution and documentation of testing, and create, review, and approve relevant QC documents, Standard Operating Procedures (SOPs), and Work Instructions (WIs). All tasks must be performed in a manner consistent with safety policies, quality systems, and cGMP requirements, ensuring that the highest standards of quality are maintained throughout the manufacturing process.

Responsibilities

• Complete QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations 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 skills are required.
• Candidates must be able to accommodate shift schedule, including 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.

Nice-to-haves

• Experience with CAR-T QC test methods and related equipment is preferred.