Operational Excellence Lead, Execution

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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 worldwide, 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 this immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking an Operational Excellence Lead, Execution as part of the Technical Operations team based in Raritan, NJ.

This position will be responsible for providing operational excellence leadership to the cGMP Commercial Cell Therapy Manufacturing plant. The individual will partner with the Raritan Site Leadership Team and various Technical Operations and Quality functions to support cell therapy operations through safe and compliant methodologies according to cGMP requirements. The role requires proven leadership and expertise that drives effective communication, coordination, collaboration across relevant cross‑functional groups to establish a strong continuous improvement and problem‑solving culture and project management to enable robust production, testing and release of product to patients.

• Plan, lead, develop, and manage an effective, holistic continuous improvement, problem‑solving culture that improves safety, compliance, cost, process stability, quality and efficiency to improve lead times and reliability for delivery of products to patients.
• Implement a continuous improvement program using lean and Six Sigma manufacturing methodologies such as standardized work, daily management system (e.g., tier process), metrics, visual tools, PDCA, Kanban, pull systems, SMED, Pareto, FMEA and others.
• Implement the routine use of disciplined problem‑solving such as DMAIC.
• Develop, teach, implement and coach the effective use of tools such as kata methodology, A3 thinking, 4
  
  Ups, 6S and others.
• Lead Kaizen events and teach others to lead and participate in such events.
• Facilitate, lead and teach others to participate and lead value stream analysis events.
• Identify and reduce sources of waste to help the site achieve its productivity goals.
• Implement strategic thinking with hoshin planning.
• Apply and teach change‑management methodology in all aspects of the plant operational excellence efforts.
• Build and lead an empowered team of OpEx professionals working toward the site objectives.
• Engage Raritan Site Leadership Team and other functional plant leaders to embody a continuous improvement mindset and culture.
• Job duties performed routinely may require limited exposure to and handling of biological materials and hazardous chemicals.
• Interact with all levels within the organization including Operations, Quality, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering.

• BS/BA required in a technical discipline:
  Engineering, science or similar field.
• Lean/Six Sigma Black Belt required;
  Master Black Belt preferred.
• Experience in several operational functions (e.g., Manufacturing, Quality, Supply Chain, Technical Operations).
• Demonstrated track record in streamlining processes, shortening lead times and reducing costs in a growing business.
• Toyota Production System training and application.
• Demonstrated ability to effectively and efficiently build teams and drive change within an organization.
• Experience in a growth environment managing the fast pace of change, balancing day‑to‑day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow.
• A history…