Associate Director, Manufacturing Operations 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 an Associate Director, Manufacturing Operations Lead as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Associate Director, Manufacturing Operations Lead will be responsible for performing the activities necessary to start up and run a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell therapy pipeline assets to patients in need. The successful candidate will first collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate the facility for the purpose of producing Phase 1 products. The following activities will include implementing manufacturing, testing and release for cell therapy product candidates.

Key Responsibilities

• Create procedures necessary to operate the GMP facility in a Phase 1 manner
• In collaboration with the development and quality teams, define the layout and activity flow for the facility along with appropriate classification
• Establish relationships with outsourced vendors such as environmental monitoring
• Establish a training program for all staff performing GMP activities
• Lead a cross-functional team to design and perform qualification activities such as aseptic process simulations, equipment qualification, etc.
• Participate in project teams to design and execute process and analytical method transfer
• Participate in project teams to design and deliver IND-enabling data for each cell therapy asset
• Direct routine manufacturing and testing of cell therapy products in collaboration with related functions including development, quality, IT, facilities, safety, and operations
• Ensure the required quality and safety standards are achieved and maintained with respect to GMP operating procedures, batch manufacturing documentation, GMP suites and compliance with the relevant phase-specific regulatory requirements

Requirements

• BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.
• Knowledge and experience with cell therapy manufacturing processes and tests
• Experience establishing and operating in a GMP environment
• Familiarity with cell therapy manufacturing and testing equipment
• Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient
• Experience working in cross-functional matrices
• Excellent collaboration skills
• Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
• Familiarity with aseptic processing

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.