Sr. Scientist, Process Development

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.  

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). 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 Sr. Scientist, Process Development as part of the Technical Development team based in Somerset, NJ. 

Role Overview

The Senior Scientist, Process Development (PD) will be responsible for developing, establishing and optimizing processes to be used in the manufacturing of Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. The candidate will have demonstrated proficiency of working in a multidisciplinary research and process development teams to define robust manufacturing processes and/or associated analytical systems, develop scalable, cGMP-compliant processes and documentation for the manufacturing of novel allogeneic cellular therapeutic products. This position requires prior experience with mammalian cell culture, process development for cellular therapies, assay development, and excellent technical, organizational, and interpersonal skills.

Key Responsibilities   

• Create and refine process development strategy for rapidly delivering phase-appropriate process development components of projects with scientific excellence and patient-focus according to Technical Development and Company’s strategic objectives.
• Work according to appropriate standards for quality, ethics, health, safety, environmental, protection and information security; lead initiatives to ensure continuous improvement; all activities must be aligned with organizational workflow and procedures.
• Drive process development activities to meet established timeline while maintaining the highest quality and data integrity standards.
• Lead efforts in tech transfer from various technologies readiness level to process development to enable GMP manufacturing to support company’s clinical trials (first-in-human/new IND).
• Ability to design, execute process development studies under defined study protocol conditions and summarize data in study reports in support of IND filings.
• Author and execute protocols and reports for technology transfer to support various stages of process transfer including R&D to CMC Development, and CMC development to manufacturing operations across internal and/or external sites.
• Ability to collaborate with quality assurance and R&D to translate research protocols and processes into formal manufacturing procedures and batch records.
• Establish and author SOPs/procedures for the developed manufacturing process for use in GMP production in a regulated environment.
• Author and review technical protocols, technical reports, and/or internal and external scientific publications.
• Ability to maintain accurate and updated lab notebooks and manufacturing records.
• Work within the team to manage equipment and records for maintenance, calibration, cleaning and operation, and maintain laboratory inventories.
• Provide technical support as SME for manufacturing root cause investigations for Deviations, CAPA. Assisting analytical/QC to investigate OOS/OOE.
• May participate in audits of 3rd party vendors as SME.
• Ability to work collaboratively within the EDD, Process and Analytical Development team, Material Science and other functional teams to establish the development strategy for new product and supply materials to support pre-clinical studies and associated activities.
• Ability to use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Provide scientific and technical guidance, actively fostering knowledge exchange. Develop, mentor