Associate Director, CMC Project Management

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 an Associate Director, CMC Project Management as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Technical Project Manager role will support/lead CMC drug development activities for clinical pipeline programs. The PM will be responsible for the coordination of technical projects, including successful planning and execution of CMC program deliverables as well as oversight throughout entire execution to ensure success as defined by adherence to standards of scope, budget, and timeline. 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 leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups.

Key Responsibilities

• Ensure that projects/deliverables adhere to program and business goals by developing and driving project plans, capturing assumptions, managing cross-functional teams, and coordinating activities within the established project timelines set forth by the Technical Program Lead and/or project team.
• Integrate timelines and strategies across functions, identifying and addressing interdependencies.
• Support scenario planning and identification of acceleration opportunities
• Monitor project progress continuously and make scheduled reports on measurable items, such as milestones and deliverables.
• Identify and track risks and ensure mitigation strategies are captured and implemented.
• Communicate proactively with all involved personnel to provide encouragement, identify problems, create solutions, and implement efficiency improvements.
• Contribute to regular program reviews (project/portfolio reviews, program strategy meetings, program risk management meetings) to accelerate program advancement, identify early critical success factors, and mitigate program risk.
• Drive CMC development strategies, activities, and timelines with responsible teams (process development, analytical development, operations, quality, regulatory) ensuring alignment with line functions and across strategic/operational plans,
• Contribute to the creation integrated project budget and resource plan in partnership with Technical Program Lead and/or functional line representatives
• Responsible for ensuring effective, accurate and timely communication of project information (meetings, minutes, action items) and coordinates interfaces with other departments.
• Hold functional teams accountable for committed objectives and timelines
• Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective. 

Requirements

• Bachelor’s and/or MS degree in scientific discipline or related field required. PMP certification preferred.
• 7-10+ years of experience managing and leading projects/programs within the biopharmaceutical industry with strong participation in project teams.
• Cell/Gene Therapy experience preferred
• Expertise in CMC drug development pertinent to cell/gene therapy manufacturing preferred
• Knowledge of regulatory guidelines and/or regulatory experience preferred
• Demonstrated success in leading and negotiating in a matrix-based organization.
• Strong track-record in executing effective project management in cross-functional teams such