GxP Application Support Lead

Company: Legend Biotech
Location: Somerset
Posted on: January 27, 2023

Job Description:

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 GxP Application Support Lead as part of the US IT team based in Somerset, NJ.
Role Overview
The GxP Application Support Lead will be responsible for leading and maintaining GxP applications used in pre-clinical, clinical, and commercial manufacturing.
Key Responsibilities

• Accountable for the controlled production support and life cycle management for multiple Cell Therapy Development (CTD) applications used by R&D, Technical Development, and Technical Operations.
• Accountable for managing day to day operational support, enabling the business to scale while improving key performance indicators impacting their efficiencies and improving overall customer experience.
• Ensure ongoing compliance with regulatory safety, GMP and Validation requirements. Ensure all systems are designed, built and operated to full SDLC requirements.
• Assist with the development and maintenance of standard operating procedures, work instructions, user guides, and other relevant documentation; provide technical consulting and perform user training with Business Systems Owners as needed.
• Assist with change control impact assessments for GxP systems changes
• Provide Tier 1-2 IT operational support for GxP environments.
• Manage and troubleshoot laboratory software with vendor support, as needed.
• Consult with Quality and IT Management to resolve complex issues in a timely manner.
• Coordinate with and manage vendors to ensure the latest software versions are compatible with systems.
  Requirements
  
  • Minimum of a Bachelor's Degree in a relevant discipline such as IT or Engineering is required, advanced degree is preferred.
  • Minimum 5 year's relevant working experience in biotech and/or pharmaceutical industries.
  • Knowledge of cell therapy applications in manufacturing
  • Excellent written and verbal communication skills
  • Ability to perform in a fast-paced working environment
  • Experience with SAP, CMMS, MES, LIMS, QMS (Veeva, Documentum, etc.)
  • Solid understanding of interfaces between MES, LIMS and ERP
  • Troubleshoot and defects resolution during validation related to integration and post go-live issue
  • Hands-on experience with pharma project execution (requirements, analysis, design definition, design review, solution implementation, testing and acceptance, traceability).
  • Knowledge of FDA and GMP guidelines
    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.
    

Keywords: Legend Biotech, Trenton , GxP Application Support Lead, Other , Somerset, New Jersey