Sr. Manager, Maintenance & Metrology

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 RD 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 Sr. Manager, Maintenance Metrology as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for maintenance and metrology support and mechanical system operations 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 leadership, 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 Leads, directs, coaches and develops an effective maintenance and metrology team that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product. Manages, plans, coordinates, staffs and prepares timely execution of daily activities related to facility operation, calibrations and corrective, preventative and predictive maintenance and repair. Ensures proper materials, 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. Manages, plans, coordinates, staffs and prepares timely execution of shutdowns. Participates or develops Cals, PMs, job plans and/or master data. Establishes and oversees Lock Out/Tag Out programs, Hot Work permits, confined space entry programs, emergency response programs and other safety programs. Assists in the creation, tracking and completion of maintenance related quality events, CAPAs, and Out of Tolerance (OOT) situations. Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems. Provides input in the development execution strategy of calibrations (Cals), preventative maintenance (PM) predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards. 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 technical and managerial leadership in area of responsibility by effectively interfacing and collaborating with key stakeholders and functio ... (truncated, view full listing at source)