QC, Analyst I

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Analyst I (IPL) as part of the Quality Operations team based in Raritan, NJ .

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. 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.

Requirements

Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development. Job duties performed require routine exposure to and handling of biological materials and hazardous chemicals.

Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required. Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required. Experience in a Quality Control setting is preferred.

Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred. Knowledge of Good Tissue Practices is required.

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 regulatory inspectors. This position may require occasional travel to partner sites in NJ or PA as business demands. This position may require up to 5% domestic or international travel as business demands.

Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities. Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.