Director, Cell and Vector Process Development

Director, Cell and Vector Process Development

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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.

We are seeking a Director, Cell and Vector Process Development as part of the Technical Development team based in Somerset, NJ.

The Director will be responsible for delivering the technical components of allogeneic cell and viral vector process development in a robust pipeline aimed at changing the course of medicine. The successful candidate will accelerate timelines, define unknowns, implement calculated risk taking, ensure phase‑appropriate compliance, and set and execute PD strategies toward early phase clinical trials in multiple geographical locations.

• Lead empowered technical teams to deliver phase‑appropriate cell and vector process development components with scientific excellence and patient focus.
• Direct the integration of cell and vector process development strategies for early phase pipelines within technical development and with related functions.
• Direct the development and execution of cell and viral vector process characterization studies to develop a phase‑appropriate understanding of operating and performance parameters; implement and maintain a state‑of‑the‑art knowledge management system.
• Provide hands‑on training as needed.
• Perform cell and vector process analysis and trend process performance.
• Lead and guide a team of scientists and technologists in execution of cell and vector process development activities associated with projects or platform establishment.
• Communicate the potential for issues and delays along with solutions and mitigation approaches.
• Creatively maximize quality, efficiency, and timeline for pipeline projects while defining unknowns.
• Collaborate with Senior Leaders, CMC Project Manager, Project Leader, and other technical leads to identify project acceleration opportunities.
• Ensure sufficient resource availability to deliver project required activities on time, including adjusting assignments to accommodate shifting demand for team members.
• Direct the cell and vector process development team to collaborate with in‑house manufacturing to start up and operate the facility.
• Enable effective and rapid decision making with proper gap assessments, including risk identification, mitigation strategy for go/no‑go criteria, and formulate reasonable assumptions.
• Establish an empowered, collaborative, science‑based, agile, innovative, continuous improvement, and patient‑focused culture within the cell and vector process development team.
• Build strong collaborative relationships among cell and vector development areas and create a culture of transparency, unity and engagement.
• Resolve conflict and proactively identify/address performance issues.
• Direct and lead troubleshooting of technical issues in cell and vector manufacturing for clinical product supply.
• Leverage science and technology to build cross‑function focused team with ability to address development and manufacturing requirements for cell and vector associated therapeutics.
• Direct and guide scientists to author technical documents including development study protocol, development study report, gaps assessment, comparability protocol, SOPs, and tech transfer documentation packages, serve as the final reviewer…