Associate Director, CMC Project Management

Overview

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 autoleucuel (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
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• 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 of 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.

• 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 as process development, clinical, regulatory, pharmaceutical sciences/technical operations in the biopharmaceutical industry.
• Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality, and risk management to teams.
• Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective.
• Superior interpersonal skills, communication skills and ability to manage conflicts and negotiations while providing impact and influence.
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong organizational, analytical, and problem-solving skills.
• Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Familiarity with project management software such as MS project, Smartsheet, think cell.
• Work independently to manage multiple projects simultaneously, making decisions and adjustments as necessary to meet deadlines and goals.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as…