Metrology Tech I

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a Metrology Tech as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require proven technical expertise and troubleshooting ability to drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients. Key Responsibilities Provides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product. Plans, coordinates, and performs timely execution of daily activities related to calibration and instrumentation. Ensures proper materials, tools, standards, parts and spare parts are identified and available. Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating procedures. Supports the planning, coordination, and performance of timely calibration during shutdowns. Responsible for performance of IFM calibration outcomes; reviews CPI/KPI/GPI where applicable. Participates in the development of calibration data sheets, metrology job plans and associated master plans. Participates in the development, implementation and sustainment of emergency response programs and other safety programs. Assists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical documentation. Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems. Helps support the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration interval extension. Partner with stakeholders assist in defining user requirements for new instruments. Responsible for working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipment. Promotes a collaborative work environment focused on an EHS first mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvement. Provides t…