Project Manager/Business Analyst

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 a Project Manager/Business Analyst as part of the IT team based in Somerset, NJ.

Role Overview

The incumbent will oversee and manage all the IT components related to the commissioning the Somerset Biomanufacturing Plant to a fully qualified GMP facility. This role requires strong leadership, organizational, communication skills to ensure that all the deliverables are tracked and completed on time, within scope and on budget. The Project Manager will work closely with cross-functional teams, stakeholders, and external partners.

Contract Duration : August 1, 2025 - December 31, 2025

Key Responsibilities

• Develop and maintain comprehensive project plans, including scope, timelines, resources, and budgets.
• Lead project teams to meet quality and compliance standards (GMP), ensuring timely execution.
• Build and maintain strong relationships with internal and external stakeholders, ensuring clear communication and alignment on project goals.
• Manage project resources, including personnel, budget, and technology, to support project success.
• Maintain project documentation, including status reports, project charters, and other relevant documents.
• Author or revise and manage the review and approval of various validation documents, SOPs, and WI required for the project.
• Work with the various business functions to draft/update user requirements of relevant IT systems to satisfy the business needs to support the process and GMP use of the facility.
• Coordinate impact assessments to identify risks of the various IT implementation with respect to regulatory and security measures.
• Identify potential risks associated with GMP facility and systems projects and develop mitigation strategies.
• Coordinate the testing (IQ/OQ, System Testing, UAT, Instrument Qualification, etc.) required for the project. This includes developing, execution, review and approval of test scripts.
• Implement change management strategies and communicate project changes as needed.
• Coordinate with engineering, facilities, and quality teams to ensure the timely installation, commissioning, and qualification of laboratory instruments and IT systems.
• Assist in updating any knowledge base articles.

Requirements

• Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 5 years' experience
• 5+ years of project management experience within a GMP-regulated environment, ideally in pharmaceutical or biopharmaceutical manufacturing.
• Experience developing and deploying IT systems (Experience in Labvantage LIMS/ELN, Veeva, Building Automation System, Environmental Management System is a plus)
• Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.
• Demonstrated ability to work independently to complete assignments within defined time constraints.
• Ability to interpret and apply GxPs, regulatory requirements
• Must have knowledge of software development lifecycle (SDLC) and of computer systems validation (CSV)
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Self-directed with a high degree of professional integrity, very organized, and detail oriented
• Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
• Strong interpersonal, oral and written communication skills are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
• Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations

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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.