MES Project Manager

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 is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.

Role Overview

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 EBR 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 (EBR) 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.

Key Responsibilities

• Lead project core teams to ensure on time project delivery.
• Leads generation and alignment of MES and / or IT project plans across functional teams Defines the interdependent deliverables for MES and / or digital projects and ensures 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.
• Drives milestone decision point planning and associated deliverables across functions to achieve the MES and / or digital project objectives. Clearly defines the critical path and generates clear decision criteria for the project.
• Develops 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.
• Prepares and manages MES governance interactions in partnership with the Project Sponsor.
• Monitors and reports on progress of the MES and / or IT project goals.
• Manages 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 EBR 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 organization.

Requirements