US: Program Lead, Cell and Gene Therapy
About The Position
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies across diverse technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. With three R&D sites globally, they apply innovative technologies to discover safe, efficacious, and cutting-edge therapeutics. Legend Biotech has a global collaboration agreement with Janssen to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) for multiple myeloma. The Program Lead, Cell and Gene Therapy, based in Raritan, NJ, is part of the Global Manufacturing and Supply team and will be responsible for developing and executing the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role involves leading strategic planning, driving execution, proposing options to senior leadership for commercial manufacturing introduction activities across late-stage and commercial programs, and ensuring technical excellence, regulatory readiness, operational execution, and seamless cross-functional alignment. The position requires close collaboration with R&D, process development, MSAT, global facility & engineering, Quality, procurement, regulatory affairs, and finance.
Requirements
- BS is required in Biotechnology, Biochemical Engineering, or related field.
- Minimum 10+ years in biopharmaceutical manufacturing.
- Viral vector late processes development/manufacturing experience is required.
- Proven experience in facility scale and layout planning, and commercial process transfer and validation.
- Strong understanding of cGMP requirements and regulatory frameworks for cell and gene therapy products.
- Strategic thinking and ability to build consensus among peers and influence senior leadership.
- Excellent project management and cross-functional leadership skills.
- Strong communication and stakeholder management capabilities.
- Ability to thrive in a fast-paced, evolving environment.
- Highly goal-oriented, ownership-driven, and laser-focused on execution.
- Comfortable navigating ambiguity and making quick, high-impact decisions.
Nice To Haves
- Ph.D. preferred in Biotechnology, Biochemical Engineering, or related field.
Responsibilities
- Define and drive the internal commercial manufacturing strategy for iLVV.
- Evaluate internal/external options for iLVV commercial manufacturing, and seek stakeholder feedback.
- Present options and recommendations to senior leadership for decision-making.
- Provide clear, concise, and timely updates to senior management regarding program progress, risks, and strategic considerations.
- Motivate and inspire cross-functional teams, building momentum, alignment, and ownership.
- Make decisive, data-driven, and sometimes tough decisions to advance program objectives under aggressive timelines.
- Develop detailed business and implementation plans and timeline for late stage clinical and commercial manufacturing to deliver launch milestones.
- Oversee facility fitness and readiness and ensure alignment with stakeholders on commercial tech transfer and production timelines.
- Partner with R&D for process development and technology transfer.
- Work closely with engineering and Somerset facility teams for infrastructure planning.
- Drive decision-making that balances scientific rigor, speed, risk, and business impact.
- Coordinate with regulatory and quality teams to ensure compliance with global standards.
- Collaborate with finance to manage budgets and cost projections.
- Working with MSAT to drive commercial process transfer activities from development to manufacturing.
- Coordinate generation of process descriptions, control strategies, equipment requirements and Bill of Materials.
- Drive establishment of raw material requirements, QC method readiness and facility fit.
- Ensure robust scale-up and validation of vector manufacturing processes.
- Ensure manufacturing facilities are prepared for the new product including capacity, equipment, utilities, and staffing.
- Partner with Supply Chain to secure long-lead materials, single-use components, and critical suppliers.
- Oversee line-of-business readiness: QA, QC, MSAT, warehouse, digital systems, labeling, analytics.
- Align on operational procedures (SOP updates, batch records, deviations/corrective actions).
- Ensure compliance with applicable global GMP, ICH, and regulatory expectations.
- Support CMC submissions, PPQ documentation, change controls, and validation packages.
- Collaborate with Quality to ensure inspection readiness and audit support.
- Identify opportunities to optimize manufacturing robustness, cost, and yield post-launch.
- Implement lessons learned, knowledge management systems, and NPI best practices.
- Support product lifecycle changes such as process improvements, site expansions, and supply chain enhancements.
Benefits
- Performance-based bonus and/or equity is available to employees in eligible roles.
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with a company match that vests fully on day one.
- Eight (8) weeks of paid parental leave after just three (3) months of employment.
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
- Flexible spending accounts
- Health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
501-1,000 employees
