BioSpace
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.
Role Overview 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.
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.
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 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.
Qualifications
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 experience 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.
Pay Range Projected base pay: $187,989 – $246,735 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options; eight weeks paid parental leave after three months; paid time off including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life & AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans for pet, critical illness, accident, and hospital indemnity; commuter benefits; family planning and care resources; well‑being initiatives; peer‑to‑peer recognition programs.
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.
Seniority Level Director
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industries Internet News
#J-18808-Ljbffr
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.
Role Overview 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.
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.
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 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.
Qualifications
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 experience 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.
Pay Range Projected base pay: $187,989 – $246,735 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options; eight weeks paid parental leave after three months; paid time off including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life & AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans for pet, critical illness, accident, and hospital indemnity; commuter benefits; family planning and care resources; well‑being initiatives; peer‑to‑peer recognition programs.
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.
Seniority Level Director
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industries Internet News
#J-18808-Ljbffr