QC Analytical Methods 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 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
• Maintain current awareness of GMP/GLP/GCP/GDP, ICH, USP, and FDA guidelines, industry standards, and trends that apply to current and future Cell Therapy Development operations and products

Requirements

• Minimum 12 years of analytical or QC experience, CAR-T experience is highly desirable.
• Cell/Gene Therapy experience preferred
• Expertise in analytical methods pertinent to cell/gene therapy manufacturing
• Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
• Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
• Expertise with methods and techniques for analysis of cell therapy products, such as Flow Cytometry, ELISA, qPCR, ddPCR, cell culture, cell count and viability measurement, and cytotoxicity assays.
• Experience with 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 strong analytical, problem solving and critical thinking skills.
• Strong experience working in a cross-functional organization with multiple partners with competing priorities.
• Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation. 

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.