Associate Director, Automation Project Management

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 an Associate Director, Automation Project Management as part of the Technical Operations team based in Somerset, NJ. 

Role Overview

 This position represents a critical technical role supporting process automation efforts within the global MSAT organization. This individual will be responsible for all technical and program management scope to drive activities ranging from strategic/business plans to managing all activities to implement a successful process automation platform in a manufacturing facility for a commercial approved Carvykti program. Specifically, this effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation platform that integrates with MES systems in cGMP manufacturing operations. This effort will extend organizationally to collaborate closely with not only technology vendor partners, but with Manufacturing, Process Development, Quality, and Regulatory to ensure approval of the selected platform.

The candidate will also be required to project manage a matrixed team of experienced cell therapy professionals whose responsibility it is to deliver a best-in-class high volume automated process platform solution. The scope comprises of building out requirements, a business case, detailed design plans, engineering and construction plans to implementation and start up. A number of evaluations will need to be developed to ensure that changes to the current process and manufacturing facility are minimized. The candidate will also be responsible for identifying new technologies and unit operations to ensure that a long-term plan for end-to-end process automation can be realized. This individual is required to drive the success and overall sustainability of a process automation program by adhering to industry best practices and sound process principles to ensure that the automation platform is comparable to the existing, but also meets or exceeds the standard of various health authorities

Key Responsibilities  

• Provide technical and program management to drive a process automation platform solution for a best-in-class CAR-T product
  
• Development of an automation concept through detailed execution, planning activities, and milestones.
  
• Program management leadership to drive strategic plans, business cases to support selected platform concept, detailed project schedule for implementation, vendor coordination and cross functional collaboration to ensure a seamless introduction in cGMP
  
• Work collaboratively with internal and external partners to identify and drive implementation of industry leading automation solutions, includes coordinating closely with teams across U.S. and Belgium locations, from equipment delivery and system integration to regulatory filing and compliance, ensuring global alignment, on-time delivery, and adherence to cGMP and other regulatory standard
  
• Drives plans for new unit operations to be evaluated and ensuring that all can be integrated into a process automation platform
  
• Identifies and drives plans for new process technologies that result in paradigm shift in
  
• Risk Management: Identify, assess, and mitigate risks across the program, including technical, operational, regulatory, and financial risks. Proactively develop and implement risk mitigation strategies to ensure project timelines, quality, and compliance are maintained.
  
• Manage contractors through all phases, from SOW definition to execution and final deliverable completion.

Requirements

• B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
  
• Minimum 12 years of process, manuf