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

• Bachelor’s Degree – Preferably in Engineering or Life Sciences.
• Minimum 10 years of Project Management experience in a GMP production environment.
• PMP certification preferred.
• Experience in biotechnology or Cell Therapy preferred.
• Experience managing others -preferred.
• Experience with managing facility/equipment/process improvement projects from specification development through full implementation in a GMP Commercial Facility.
• Experience with Asset Change Control, Process/System Improvement, Asset Lifecycle activities/documentation.
• Excellent knowledge of project management discipline and its application to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.
  
• Experience with Healthy Authority requirements and regulatory submission activities preferred.

Benefits

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.