About the Role
The QA Investigator is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.
A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
Ability to identify/remediate gaps in processes or systems.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
About the Company
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 Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Contact/How to apply