MES Project Manager

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

The individual will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to establish a strong project management office to enable robust EBR and IT solutions for production of product to patients. This individual will also be responsible for gaining the necessary process knowledge of the product to assist with development of EBR designs that fit the site’s needs. The major responsibilities will include but are not limited to:

• 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

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree and PMP certification strongly preferred.
• A minimum of 7 years of relevant experience is required. Demonstrated experience translating business needs to system requirements and planning and leading multiple complex projects/programs within biopharmaceutical industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
• Must have experience creating a highly collaborative and inclusive environment necessary for the team to be effective.
• Strong track record in executing effective project management in cross-functional teams within IT, clinical, regulatory, pharmaceutical sciences/technical operations in the biopharmaceutical industry.
• Demonstrated results in creating and managing complex program plans. Having experience with global teams, budgetary management, resource planning, and fiscal awareness is preferred.
• Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities.
• Lean experience with practical application. Yellow belt certified a plus, green belt certified preferred.
• Ability to engage all levels of the organization, from site leadership to the shop floor.
• Accurately and reliably gauge task effort and plan work to meet project timelines
• 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.
• 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 coordination of 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. 

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