Legend Biotech
Associate Director, CMC Project Management
Legend Biotech, Trenton, New Jersey, United States
Associate Director, CMC Project Management
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 (CAR‑T), T‑cell receptor (TCR‑T) and natural killer (NK) cell‑based immunotherapy. From our three R&D sites worldwide, 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, a Johnson & Johnson pharmaceutical company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview The Technical Project Manager will support and lead CMC drug development activities for clinical pipeline programs. The PM is responsible for coordinating technical projects, planning and executing CMC program deliverables, overseeing execution to ensure adherence to scope, budget and timeline, and establishing and reporting on key project/program metrics to support on‑time and on‑budget outcomes. The role requires leadership that drives effective communication, coordination and collaboration across relevant cross‑functional groups.
Key Responsibilities
Develop and drive project plans, capturing assumptions and managing cross‑functional teams to ensure projects/deliverables adhere to program and business goals.
Integrate timelines and strategies across functions, identifying and addressing interdependencies.
Support scenario planning and identify acceleration opportunities.
Monitor project progress continuously and report on measurable items, such as milestones and deliverables.
Identify and track risks and ensure mitigation strategies are captured and implemented.
Communicate proactively with all involved personnel to provide encouragement, identify problems, create solutions and implement efficiency improvements.
Contribute to regular program reviews (project/portfolio reviews, program strategy meetings, program risk management meetings) to accelerate program advancement and mitigate risk.
Drive CMC development strategies, activities and timelines with responsible teams (process development, analytical development, operations, quality, regulatory) ensuring alignment with line functions and across strategic/operational plans.
Contribute to the creation of an integrated project budget and resource plan in partnership with the Technical Program Lead and/or functional line representatives.
Ensure effective, accurate and timely communication of project information (meetings, minutes, action items) and coordinate interfaces with other departments.
Hold functional teams accountable for committed objectives and timelines.
Create a highly collaborative and inclusive environment to enable the team’s effectiveness.
Requirements
Bachelor’s and/or MS degree in a scientific discipline or related field; PMP certification preferred.
7‑10+ years of experience managing and leading projects/programs within the biopharmaceutical industry.
Cell/Gene Therapy experience preferred.
Expertise in CMC drug development pertinent to cell/gene therapy manufacturing preferred.
Knowledge of regulatory guidelines and/or regulatory experience preferred.
Demonstrated success in leading and negotiating in a matrix‑based organization.
Strong track record in executing effective project management in cross‑functional teams such as process development, clinical, regulatory, pharmaceutical sciences/technical operations.
Excellent knowledge of project management discipline and its application to drug development to deliver time, cost, quality and risk management.
Superior interpersonal, communication and conflict‑resolution skills with ability to influence and provide impact.
Capacity to manage shifting priorities and meet critical deadlines in a fast‑paced, dynamic environment while providing clear direction to team members.
Strong organizational, analytical and problem‑solving skills.
Ability to build strong partnerships and integrate with external collaborators in a matrixed environment.
Familiarity with project management software such as MS Project, Smartsheet, ThinkCell.
Work independently managing multiple projects simultaneously, making decisions and adjustments to meet deadlines and goals.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. Our best‑in‑class benefits package supports well‑being, financial stability and long‑term career growth. Highlights include medical, dental and vision insurance; a 401(k) retirement plan with matching that vests fully on day one; equity and stock options (eligible roles); eight weeks of paid parental leave after just three months of employment; paid time off (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, 3 floating holidays); flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans (pet, critical illness, accident, 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. The company’s policy ensures equal employment opportunity through a prohibition of discrimination or harassment on the basis of 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 either party. Legend may adjust base salary or other discretionary compensation at any time based on performance or market conditions. Legend Biotech maintains a drug‑free workplace.
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Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson pharmaceutical company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview The Technical Project Manager will support and lead CMC drug development activities for clinical pipeline programs. The PM is responsible for coordinating technical projects, planning and executing CMC program deliverables, overseeing execution to ensure adherence to scope, budget and timeline, and establishing and reporting on key project/program metrics to support on‑time and on‑budget outcomes. The role requires leadership that drives effective communication, coordination and collaboration across relevant cross‑functional groups.
Key Responsibilities
Develop and drive project plans, capturing assumptions and managing cross‑functional teams to ensure projects/deliverables adhere to program and business goals.
Integrate timelines and strategies across functions, identifying and addressing interdependencies.
Support scenario planning and identify acceleration opportunities.
Monitor project progress continuously and report on measurable items, such as milestones and deliverables.
Identify and track risks and ensure mitigation strategies are captured and implemented.
Communicate proactively with all involved personnel to provide encouragement, identify problems, create solutions and implement efficiency improvements.
Contribute to regular program reviews (project/portfolio reviews, program strategy meetings, program risk management meetings) to accelerate program advancement and mitigate risk.
Drive CMC development strategies, activities and timelines with responsible teams (process development, analytical development, operations, quality, regulatory) ensuring alignment with line functions and across strategic/operational plans.
Contribute to the creation of an integrated project budget and resource plan in partnership with the Technical Program Lead and/or functional line representatives.
Ensure effective, accurate and timely communication of project information (meetings, minutes, action items) and coordinate interfaces with other departments.
Hold functional teams accountable for committed objectives and timelines.
Create a highly collaborative and inclusive environment to enable the team’s effectiveness.
Requirements
Bachelor’s and/or MS degree in a scientific discipline or related field; PMP certification preferred.
7‑10+ years of experience managing and leading projects/programs within the biopharmaceutical industry.
Cell/Gene Therapy experience preferred.
Expertise in CMC drug development pertinent to cell/gene therapy manufacturing preferred.
Knowledge of regulatory guidelines and/or regulatory experience preferred.
Demonstrated success in leading and negotiating in a matrix‑based organization.
Strong track record in executing effective project management in cross‑functional teams such as process development, clinical, regulatory, pharmaceutical sciences/technical operations.
Excellent knowledge of project management discipline and its application to drug development to deliver time, cost, quality and risk management.
Superior interpersonal, communication and conflict‑resolution skills with ability to influence and provide impact.
Capacity to manage shifting priorities and meet critical deadlines in a fast‑paced, dynamic environment while providing clear direction to team members.
Strong organizational, analytical and problem‑solving skills.
Ability to build strong partnerships and integrate with external collaborators in a matrixed environment.
Familiarity with project management software such as MS Project, Smartsheet, ThinkCell.
Work independently managing multiple projects simultaneously, making decisions and adjustments to meet deadlines and goals.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. Our best‑in‑class benefits package supports well‑being, financial stability and long‑term career growth. Highlights include medical, dental and vision insurance; a 401(k) retirement plan with matching that vests fully on day one; equity and stock options (eligible roles); eight weeks of paid parental leave after just three months of employment; paid time off (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, 3 floating holidays); flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans (pet, critical illness, accident, 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. The company’s policy ensures equal employment opportunity through a prohibition of discrimination or harassment on the basis of 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 either party. Legend may adjust base salary or other discretionary compensation at any time based on performance or market conditions. Legend Biotech maintains a drug‑free workplace.
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