Laboratory Automation Integration Expert

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 Laboratory Automation Integration Expert (Contract/Consultant) as part of the Global MSAT team based in Raritan, NJ.

Role Overview

This position represents a critical technical role supporting analytical automation efforts within the global MSAT organization. This individual will be responsible for the technical and program management scope to drive activities ranging from strategic/business plans, to managing all activities to implement a successful analytical automation platform for the commercial Carvykti program. Specifically, this effort will include scope related to both flow and plate based analytical assays and will incorporate an automation platform that integrates with eLIMS and MES to manage samples from manufacturing in cGMP through final testing results.  This effort will extend organizationally to collaborate closely with Process & Analytical Development as well as broader functional partners. The candidate will also be required to build and manage a matrixed team of experienced cell therapy professionals whose responsibility it is to deliver a best-in-class high volume automated analytical platform solution. The scope comprises of defining changes to current analytical methods to enable automation integration to identifying new technologies for all release assays to reduce sample time and increase throughput for a future business state. This individual is required to drive the success and overall sustainability of an analytical automation program by adhering to industry best practices and sound analytical principles to ensure that all methods includes in the automation platform are both comparable to the existing, but meet or exceed the standard of various health authorities

Key Responsibilities  

• Provide technical and program management to drive an analytical automation platform solution for a best-in-class CAR-T product.
• Development of an automation concept through detailed execution planning activities and milestone
• Program management leadership to drive the 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
• Drives plans for modification of existing analytical methods and ensuring that all methods are able to be integrated into an analytical automation platform
• Identifies and drives plans for new analytical technologies that result in paradigm shift in throughput and capacity

Requirements

• B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
• Minimum 12 years of analytical or QC experience, CAR-T experience is highly desirable.
• Experience in implementing and managing commercial analytical method improvements and changes
• Experience in developing and implementing solutions with industry leading commercial analytical automation partners
• Experience in integrating analytical methods into an automation platform
• Candidate must have program management expertise in the life sciences field
• Extensive experience in analytical automation technology and vendor offerings specific to commercial analytical platforms, liquid handling & sample handling systems
• Extensive knowledge in analytical best practices, industry standards and the latest technologies
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Results driven with stro