QC Analytical Methods Expert (Consultant)

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 QC Analytical Methods Expert (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. The candidate must have strong laboratory skills, bioassay, cell biology and immunology experience. This individual will be providing specialist knowledge and expertise of cell and gene therapy analytical methods, for a commercially approved product. Specifically, this effort will include scope related to both flow and plate based analytical assays and will help design the automation platform that integrates with eLIMS and MES to manage samples from manufacturing in cGMP through final testing results. 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. Expertise is also required in managing and implementing transfers of qualified, validated and comparable test methods approved for the commercial program. This position will actively interact with internal MFG/AD/QC/QA team and external client SMEs to develop and drive the strategy and supporting business cases to ensure the successful delivery of a commercial CARVYKTI automation platform. The ideal candidate for this position should have work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH .

Key Responsibilities  

• Subject matter expert of QC analytical methods in the areas of ELISA, qPCR, ddPCR assays, cell bioassays, Flow Cytometry and Rapid Sterility.
• Evaluate analytical methods for feasibility, method improvement, remediation, and/or troubleshooting  
• Work with the software team on integration solutions for the QC process and data management, including MES, QMS, and LIMS 
• Work collaboratively with internal and external partners to identify and drive implementation of industry leading automation solutions  
• Coordinate and collaborate with AD/QC team in analytical method development and characterization of products that are currently in development 
• Identify, assess, and implement new technologies to improve product quality, success rate, reproducibility and/or reduce cost and time of the analytical processes 
• 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