Location: Somerset,NJ, USA
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 Senior Scientist, Process Development as part of the Technical Development team based in Somerset, NJ.
Role Overview
To further develop and support autologous and allogeneic cellular therapy products, with focus on allogeneic CAR NK. The responsibilities would span CMC program development at all levels, from initial transfer from R&D, assessment of new technologies, developing robust manufacturing processes (cell selection, activation, gene modification, expansion, and harvest), to technology transfers and support of GMP manufacturing. This individual will collaborate with partner functions such as research and development, analytical development, material sciences, quality, regulatory, manufacturing and supply chain to advance pipeline programs
Key Responsibilities
* Act as a technical lead for emerging autologous and allogeneic cell therapy product manufacturing with a focus on NK allogeneic platform
* Design, execute, and interpret complex process development experiments
* Coordinate, author, and review technical documents, protocols, and reports.
* Analyze, organize, and present data in clear and concise manner.
* Maintain laboratory notebooks and prepare protocols and reports in a GMP-compliant manner
* Work closely with internal and external partners to evaluate, develop, execute technology transfers and lead the implementation of new process technologies
* Author technical documents to support regulatory filings
* Generation of drug product representative material for IND-enabling studies
* Participate in GMP manufacturing campaigns for in-house products
* Collaborate with internal quality representatives to ensure GMP practices are followed by internal and external partners.
* Conduct technical discussions & meetings with internal stakeholders including procurement, quality, development and finance, and facilitate implementation of new cellular technologies.
Requirements
* PhD or MS in Cell Biology, Immunology, Biomedical Engineering, or other related discipline.
* Minimum of 5 years' experience in biotechnology, bioprocessing, GMP manufacturing, or cell therapy development
* Experience working with human samples, specifically NK primary cells
* Experience with feeder cell lines and irradiation of feeder cells
* Experience with technology transfers
* Expertise in technical development pertinent to cell/gene therapy manufacturing
* Ability to build strong partnerships and effectively integrate with internal and 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
* Adept at working collaboratively with cross-functional teams
* Knowledge in process development of cell therapy products.
* Knowledge in NK cell biology and immunology.
* Knowledge of gene editing (ie. viral vector, electroporation)
* Ability to interpret, report, and present data or findings.
#Li-JK2
#Li-Hybrid
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.