Quality Project Management Specialist

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 Quality Project Management Specialist as part of the Quality team based in Raritan, NJ. 

Role Overview

This position is an exempt level position. The position’s responsibilities include providing quality oversight over process improvement projects within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will support quality activities for continuous improvement efforts, site escalations, and quality projects. 

Key Responsibilities  

• Provide quality and compliance input for identified continuous improvement efforts associated with the manufacturing site.
  
• Lead assigned Quality tasks associated with process improvements.
  
• Participate/facilitate in escalations associated with batch investigations.
  
• Provide site Quality metrics.
  
• Collaborates with all Quality groups and functional departments to resolve issues.
  
• Provide quality support in cross-functional projects with many stakeholders.
  
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
  
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; escalates to management when problems are identified, consult with supervisor or other subject matter experts for decisions outside established processes.
  
• Drive continuous improvement.

Requirements

• A minimum of a Bachelor’s Degree
• A Minimum of 5 years relevant work experience is required. It is preferable that the candidate have 2 years + of experience working in Quality Assurance. Previous cell therapy experience is a plus
• Knowledge of cGMP regulations and Health Authority guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
  
• Ability to lead projects
  
• Ability to facilitate meetings
  
• Participated in Health Authority Inspections is a plus
  
• Drive Change
  
• Strong interpersonal and written/oral communication skills
  
• Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities.
  
• Ability to independently perform assigned tasks.
  
• Ability to work with in a team environment.
  
• Ability to identify/remediate gaps in Quality processes or systems.
  
• Proficient with using Microsoft Office applications
• Language: English

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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.