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 develop advanced cell therapies across multiple platforms to discover safe, efficacious, and cutting‑edge therapeutics for patients worldwide.

Our partnership with Janssen, a Johnson & Johnson company, supports joint development and commercialization of the ciltacabtagene autolecuel (cilta‑cel) for multiple myeloma.

Raritan, NJ

The MES Project Manager reports to the Manufacturing Execution Systems Lead and provides project management support for electronic batch record (E ) updates and digital solutions at the Raritan site. The role coordinates with Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT to manage project plans, deliverables, and key metrics.

• Lead project core teams to ensure on‑time project delivery.
• Generate and align MES and/or IT project plans across functional teams, defining interdependent deliverables and managing quality, risk, cost, and time to meet milestones.
• Drive milestone decision‑point planning and deliverables across functions to achieve project objectives.
• Develop options and solutions to complex project risk problems, providing guidance to leadership on trade‑offs and implications.
• Prepare and manage MES governance interactions in partnership with the Project Sponsor.
• Monitor and report progress of the MES and/or IT project goals.
• Manage an integrated project budget and resource plan with Project Sponsors, Finance, and functional line representatives.
• Develop and manage the communication plan, ensuring effective, accurate, and timely communication of project information.
• Coordinate with departments to gather user requirements and deliver robust, right‑first‑time E  designs.
• Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).
• Coordinate MES validation activities according to the Software Development Life Cycle.
• Support defining standardizations and updates to SOPs, WIs, Technical & Design Specifications, and Qualification Protocols aligned with Global Procedures.
• Establish key stakeholder relationships with internal and external stakeholders.

• Minimum of a bachelor’s degree in engineering or a related field, or equivalent experience; advanced degree and PMP certification strongly preferred.
• Minimum of 7 years of relevant experience translating business needs to system requirements and leading multiple complex projects/programs in the biopharmaceutical industry.
• Experience with Cell/Gene Therapy cGMP manufacturing preferred.
• Strong track record in executing effective project management in cross‑functional teams within IT, clinical, regulatory, and pharmaceutical sciences/technical operations.
• Demonstrated results in creating and managing complex program plans, budgeting, resource planning, and fiscal awareness.
• Technical expertise of the Change Control process and oversight of the MES team.
• Lean experience with Yellow Belt certification a plus, Green Belt certification preferred.
• Ability to engage all levels of the organization, from site leadership to shop floor.
• Accurate task effort estimation and scheduling to meet project timelines.
• Independent, self‑motivated, prioritizing and managing multiple tasks simultaneously in a fast‑paced environment.
• Cross‑functional collaboration with Technical Operations and IT to design and implement system updates for cell therapy development and manufacturing.
• Support coordination of studies related to process improvement and new manufacturing execution system technologies.
• Strong analytical, problem‑solving, and critical thinking skills; leadership as a change agent promoting flexibility, creativity, and accountability.

We offer a best‑in‑class benefits package including medical, dental, and vision insurance, a 401(k) retirement plan with company match vesting fully on day one, equity and stock options for eligible roles, eight weeks of paid parental leave after three months, and paid time off encompassing 15 vacation days, 5 personal days, 5 sick days,…