Strategic Initiatives & Capacity Expansion Project Manager

Strategic Initiatives & Capacity Expansion 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.

Role Overview

This position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant Leadership and all applicable site functions in support of personalized cell therapy production through safe and compliant project implementation in cGMP production environment. The individual will be responsible for management and delivery of the integrated project and program plans, ensuring alignment in support of the overall objectives and priorities of the plant. 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. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups.

Key Responsibilities

• Lead projects for the implementation of site strategic initiatives and capacity expansion activities from identification through implementation.
• Work with cross-functional teams to develop a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.
• Drive capacity evaluations and lead action implementation to support site ramp up plans.
• Monitors capacity enabling resource availability such as headcount, materials, equipment, and associated projects.
• Leads generation and alignment of integrated project plans with supporting functional areas.
• Manage project portfolio for site's Strategic Initiatives Team.
• Defines the interdependent deliverables 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 overall 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 governance interactions in partnership with the Project / Initiative Sponsor and Lead.
• Manages an integrated project and resource plan for Strategic Initiatives Team in partnership with the Project leads and functional line representatives on the teams.
• Responsible for development and management of the communication plan for the project. Monitors and reports on progress of the project goals.
• Collaborate between all site functions to ensure timely implementation of strategic initiatives and capacity related projects.
• Assist with Audits and / or authoring and coordinating response to Healthy Authority information requests associated with executed capacity studies, as needed.
• Coordinates the development of operational models to meet clinical and commercial demand.

Requirements