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

Role Overview

The Director, Cell and Vector Process Development, 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. He/she will maximize the value of company assets by accelerating timelines, defining unknowns, implementing calculated risk taking, ensuring phase-appropriate compliance, and setting and executing PD strategies towards early phase clinical trials in multiple geographical locations. The successful candidate will work closely within the technical teams to ensure on-time execution and adaptation to dynamic development priorities. The position demands strong strategic, technical and dynamic leadership within a collaborative, science-based, and patient-focused environment. The candidate will have deep knowledge and hands-on experience in establishing processes from R&D for development and early phase GMP manufacturing.

Key Responsibilities

• 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.
• In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical leads identify project acceleration opportunities.
• Ensure sufficient resource availability to deliver project required activities on time, including adjusting assignments to accommodate shifting demand for self and individuals within the team.
• 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 and approval prior to execution.
• Direct the support of scientists to author components of CMC sections of regulatory submissions.
• Ensure compliance with regulatory requirements.
• Direct the creation and execution of strong employee development plans enabling staff readiness for future challenges delivering impactful technologies to patients.

Requirements

• Advanced degree (MS, PhD) in biomedical or chemical engineering, biology and/or virology, molecular biology or equivalent.
• 10+ years of experience with process development and/or manufacturing in a biotech, academic, or pharmaceutical setting.
• Extensive experience establishing platform and manufacturing processes to supply clinical trials for autologous and/or allogeneic clinical trials
• Deep technical expertise in cell therapy process development and process transfer to manufacturing for implementation
• Deep technical expertise in LVV manufacturing using bioreactors and pilot-scale downstream processes
• Strong understanding of CMC requirements for early phase cell and vector development and manufacturing
• Deep knowledge and hands-on experiences in cell and lentiviral vector technologies within the current emerging field
• Ability to implement closed-system processes and maximize cost effectiveness
• Excellent leadership, emotional intelligence, and communication skills
• Demonstrated proficiency preparing regulatory submissions
• Proven track record of advancing developed cell and lentiviral vector platform into first in human and/or late-stage clinical trials
• Creative, strategic thinking
• Composure during challenging times
• Strong troubleshooting skills
• Language: English, Mandarin is a plus

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The anticipated base pay range is:

$187,989—$246,735 USD

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.