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 Manufacturing Execution Systems Lead as part of the Manufacturing Excellence team based in Raritan, New Jersey.

Role Overview

The Manufacturing Execution Systems Lead will be part of Manufacturing Excellence and will be responsible for overseeing the manufacturing execution system (MES) utilization at the Raritan site to support production processing while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will oversee electronic batch record (EBR) updates and system improvements and integrations, support applicable process and facility updates, and support qualification activities associated with MES/EBR updates.

Key Responsibilities

This individual will have the necessary process knowledge of the product and will maintain oversight on MES capability to optimize process execution and system utilization at the site. This individual will also identify opportunities for system improvements, develop improvement projects, and drive implementation strategy.

This individual will be responsible for managing MES base business which includes but is not limited to the following:

• Change Intake, Coordination, and Backlog Management
• MES Quarterly Releases / Documentation Updates
• Technical Support of MES
• MES Assessments for CCs, NCs, CPA/Corrections
• Audit Readiness and Support (Front/Backroom)
• Site Escalations Support acting as MES SME(s)
• MES Training Curriculum Ownership and Updates
• Delivery of Raritan Site Projects
• This individual will also be responsible for the site system strategy and managing the interdependencies with site’s base business
• This individual will oversee the hiring, development, and performance management of MES system specialists, and assign personnel to base business tasks as applicable
• This individual is responsible for the training of Manufacturing Excellence on MES utilization and ensuring that Manufacturing Excellence properly assesses updates and impact
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization

Requirements

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred
• A minimum of 6 years of relevant experience is required. Demonstrated experience leading team(s) and translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and supervisory experience preferred
• Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities
• Work closely with the development and MS&T organization to ensure translation of changes from concept to implementation, building long term implementation and support plans
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk, and priority
• Drive the implementation of MES enhancements that would provide reduction in COGs, and increase throughput, capacity, and quality compliance
• Work cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy development and manufacturing
• When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies
• An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
• Clear and succinct verbal and written communication skills.

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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.