Vice President US Manufacturing and Supply, Cell Therapy Facility GM

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 Vice President US Manufacturing and Supply, Cell Therapy Facility GM as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

This position is responsible for overseeing all aspects of cGMP manufacturing and supply for a commercial Cell Therapy Manufacturing organization, primarily serving the US market. The scope includes everything from raw material procurement to Drug Product release and patient shipment. Additionally, the role encompasses organizational development, operations scale-up, and the facility expansion of a state-of-the-art cell therapy manufacturing site.

The role ensures the establishment of key business processes and effective reporting systems to support reliable commercial and clinical supply. It also involves leading communication and collaboration across cross-functional teams to guarantee the robust production, testing, and release of products. The position requires strong leadership to guide the organization toward world-class standards through best-in-class manufacturing principles, processes, technologies, and talent management.

Key Responsibilities   

• Develop and lead an effective manufacturing and supply organization, supporting teams for the commercial supply of a CAR-T product in the US market.
• Provide both technical and managerial leadership across all cGMP-related responsibilities. Lead and ensure strong delivery in areas such as Procurement, Planning, Warehouse, Manufacturing Science and Technology, Technical Support, Facility & Engineering, Project Management, and Operational Excellence, with indirect responsibility and cross-functional collaboration in Quality, Finance, and HR.
• Manage and oversee the site’s manufacturing and supply budget and performance.
• Foster a collaborative environment, emphasizing a strong culture of quality and continuous improvement within the organization.
• Ensure that product quality, manufacturing costs, throughput, equipment, operator performance, employee safety, and housekeeping standards are consistently established, monitored, and maintained.
• Develop a strategy to enhance talent, focusing on delivering the highest standards while building organizational bench strength and ensuring robust succession planning.
• Continue to build bench strength in entire site organization and ensure robust succession planning

Requirements

Education: B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field

Experience:

• Minimally 15+ years of combined experience in cGMP manufacturing, operations management, tech transfer, process and equipment validation and quality management, with a preference for cell therapy experience
• Minimum of 5 years of experience in a leadership role in Biologics and/or cell therapy operations
• Demonstrated ability to build effective and efficient 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 of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
• Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situati