US: Program Lead, Cell and Gene Therapy

Legend Biotech is seeking a Program Lead, Cell and Gene Therapy as part of the Global Manufacturing and Supply team based in Raritan, NJ.

Role Overview

The program Lead will be responsible for developing and executing the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role will lead strategic planning, drive execution, propose options to senior leadership, of the commercial manufacturing introduction activities across late-stage and commercial programs, ensuring technical excellence, regulatory readiness, operational execution, and seamless cross-functional alignment. The position requires close collaboration with cross-functional teams including R&D, process development, MSAT, global facility & engineering, Quality, procurement, regulatory affairs, and finance.

Key Responsibilities

Strategic Leadership

• 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.

Planning & Execution:

• 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.

Cross-Functional Collaboration

• 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.

Process Development & Transfer

• 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.

Manufacturing Site & Operational Readiness

• 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).

Quality and Compliance

• 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.

Continuous Improvement & Lifecycle Management

• 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.

Requirements

Education

BS is required, Ph.D. preferred in Biotechnology, Biochemical Engineering, or related field.

Experience

• 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.

Skills

• 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.

#Li-BZ1

#Li-Hybrid