Program Lead, Cell and Gene Therapy

Program Lead, Cell and Gene Therapy Legend Biotech is a global biotechnology company dedicated to treating and curing life‑threatening diseases. We are developing advanced cell therapies across diverse technology platforms and have a collaboration with Janssen to develop ciltacabtagene autolecuel (cilta‑cel) for multiple myeloma. Location : Raritan, NJ. Team : Global Manufacturing and Supply. Role Overview The Program Lead will develop and execute the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role leads strategic planning, drives execution, proposes options to senior leadership, and manages cross‑functional alignment across R&D, process development, MSAT, 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, seek stakeholder feedback, and present recommendations to senior leadership. Provide concise updates to senior management on program progress, risks, and strategic considerations. Motivate cross‑functional teams, build momentum, alignment, and ownership. Make decisive, data‑driven decisions to advance program objectives under aggressive timelines. Planning & Execution Develop detailed business and implementation plans and timelines for late‑stage clinical and commercial manufacturing launch milestones. Oversee facility fitness and readiness, ensuring 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 Drive commercial process transfer activities from development to manufacturing with MSAT. 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 required; Ph.D. preferred in Biotechnology, Biochemical Engineering, or related field. Experience 10+ years in biopharmaceutical manufacturing; viral vector late‑process development/manufacturing experience required. Proven experience in facility scale and layout planning, 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 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, laser‑focused on execution. Comfortable navigating ambiguity and making quick, high‑impact decisions. Benefits and Paid Time Off Medical, dental, and vision insurance; 401(k) retirement plan with company match; 8 weeks of paid parental leave after 3 months; vacation, personal, sick, floating holidays, and 11 company holidays. Additional voluntary benefits include flexible spending accounts, health savings accounts, life and AD&D insurance, disability coverage, legal assistance, and supplemental plans. EEO Statement Legend Biotech provides equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or expression, sexual orientation, marital status, military service, veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state, or local laws. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. For information related to our privacy notice, please review: Legend Biotech Privacy Notice. #J-18808-Ljbffr