MES Project Manager

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 MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ
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The MES Project Manager will be part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to the development and administration of E  and digital solutions at the Raritan site to support base business 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 be responsible for management and delivery of the project plans for electronic batch record (E ) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS‑X). This position will also be responsible for establishing and reporting on key project/program metrics in support of on‑time and on‑budget project deliverables.

• Lead project core teams to ensure on time project delivery.
• Lead generation and alignment of MES and/or IT project plans across functional teams. Define the interdependent deliverables for MES and/or digital projects and ensure that quality, risk, cost, time are managed within the overall approved plan to drive delivery of project milestones and objectives on time and on budget.
• Drive milestone decision point planning and associated deliverables across functions to achieve the MES and/or digital project objectives. Clearly define the critical path and generate clear decision criteria for the project.
• Develop options and solutions to complex project risk problems, providing guidance to leadership including trade‑off and implications assessment (value, risk, cost, time) to the project or program.
• Prepare and manage MES governance interactions in partnership with the Project Sponsor.
• Monitor and report on progress of the MES and/or IT project goals.
• Manage an integrated project budget and resource plan in partnership with the Project Sponsors, Finance team member, and functional line representatives within the MES core team.
• Responsible for development and management of the communication plan for the MES / digital project, including stakeholder management.
• Responsible for ensuring effective, accurate and timely communication of project information.
• Coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right first time E  designs.
• Preference for candidates to have relevant experience supporting MES and/or digital enhancements within a GMP site.
• Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).
• Coordinate MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ).
• Support defining standardizations and update documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the…