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Senior Project Manager Equipment C&O

Somerset, New Jersey, United States

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 a Senior Project Manager Equipment C&O as part of the Global Operations team based in Somerset, NJ. 

Role Overview

This position will be responsible for providing project management support for the Engineering & Technical Development teams cGMP Clinical Cell Therapy Manufacturing plant. This individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe and compliant project implementation in cGMP production environment. The individual will be responsible for management and delivery of the integrated project and program plans, ensuring alignment in support of the overall objectives and priorities of the plant. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget project deliverables. The role will require proven leadership and expertise that drives effective communication,
coordination and collaboration across relevant cross functional groups.

Key Responsibilities  

  • Lead projects for the implementation of system/equipment changes from identification through commissioning/qualification and release, including the associated Change Controls.
  • Leads generation and alignment of integrated project plans across functional teams.
  • Manage project portfolio for site’s Equipment Team.
  • Defines the interdependent deliverables and ensures that quality, risk, cost, time are managed within the overall approved plan to drive delivery of project milestones and objectives on time and on budget.
  • Drives milestone decision point planning and associated deliverables across functions to achieve the overall project objectives. Clearly defines the critical path and generates clear decision criteria for the project.
  • Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications assessment (value, risk, cost, time) to the project or program.
  • Prepares and manages governance interactions in partnership with the Project Sponsor.
  • Monitors and reports on progress of the project goals.
  • Manages an integrated project budget and resource plan in partnership with the Project Sponsors, Finance team member, and functional line representatives on the team.
  • Responsible for development and management of the communication plan for the project, including stakeholder management.
  • Ensures development of asset lifecycle documentation from URS development to asset retirement.
  • Leads projects to address complex technical equipment issues and/or asset optimizations.
  • Ensure applicable equipment adheres to all CSV and data integrity guidelines and assist with data acquisition system activities.
  • Collaborate between equipment owner > process engineering > engineering and facilities > commissioning and qualification > quality to ensure timely implementation of project. 

Requirements

  • Bachelor’s Degree – Preferably in Engineering or Life Sciences
  • Minimum 10 years of Project Management experience with Facility, Engineering, and/or Commissioning/Qualification projects in a GMP production environment.
  • PMP certification preferred.
  • Experience in biotechnology or Cell Therapy preferred
  • Experience managing others -preferred
  • Experience with managing facility/process equipment projects from specification development through full implementation in a GMP Commercial Facility.
  • Experience with Commissioning/Qualification, Asset Change Control, Process/System Improvement, Asset Lifecycle activities/documentation.
  • Excellent knowledge of project management discipline and its application to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
  • Strong organizational skills.
  • Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional requirements and balance competing priorities effectively.
  • Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
  • Strong understanding of regulatory and compliance requirements
  • Excellent oral and written communication skills
  • Highly collaborative and inclusive
  • Ability to effectively mentor and coach junior team members

#Li-Hybrid

#Li-LB1

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 law.

Legend Biotech maintains a drug-free workplace.

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