Associate Technical Lead

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 Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Associate Technical Lead will be part of Technical Operations and will be responsible for supporting the Manufacturing Excellence team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and / or process technologies. This individual will also oversee the processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

Key Responsibilities

• This individual with provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical Operations and ensure safe and compliant manufacturing operations according to cGMP requirements.
• This individual will support the hiring and development of Manufacturing Excellence associates.
• This individual will also own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving.
• Work with the Data Management and Integration Lead and Process Validation lead on the establishment and management of a process monitoring program.
• Establish metrics for process and team performance. Ensures seamless flow of knowledge and information across functions, and with other sites when applicable.
• Provides technical / scientific process support. Support manufacturing investigations, support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections.
• This individual will also support the implementation of manufacturing and process automation strategies through cell therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered autologous T cell therapy products.
• Write and / or review user requirements, functional requirement specifications, qualification protocols, enterprise or system interface, process development reports, and provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements.
• Work closely with cross-functional teams to design and implement cell therapy processes, manage equipment qualification strategy, and support process validation activities for cell therapy platforms.

Requirements

Li-Hybrid

Li-JK1

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.