Cleaning Validation Lead

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 Cleaning Validation Lead as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Cleaning Validation Lead will be responsible for creating and maintaining the cleaning validation program for the Cell Therapy facility following necessary FDA / Annex 1 requirements. This person will be the lead for cleaning validation program, working cross functionally with various departments to ensure equipment and facility are proper disinfected. This role will require microbial and engineering technical expertise and troubleshooting ability and shall drive effective communication, coordination and collaboration across relevant cross functional groups. This individual will be an integral part of the CAR-T Environmental Monitoring Immediate Action team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.

Key Responsibilities

• The Cleaning Validation Lead will establish and maintain the cleaning validation program / strategy for the site.
• The role is responsible for ensuring the program aligns across sites in the network and responsible for presenting the strategy in health authority inspections.
• Ensure site alignment with the manufacturing control strategy and microbial control strategy.
• Assess change controls and SOPs/Work Instructions for cleaning validation impact.
• Support Facility expansion activities including having a robust cleaning validation approach and integration with the existing facility.
• Support training of new and existing employees on the rational for proper cleaning / disinfecting of equipment/personnel.

Requirements

• Bachelor's Degree – Preferably in Engineering or Life Sciences
• Minimum 5 years of experience in Technical, Engineering, and/or Operations in a GMP production environment
  
• Experience conducting, supporting, reviewing and approving cleaning efficacy studies
  
• Experience in biotechnology or Cell Therapy preferred
  
• Experience with GMP equipment
• Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
  
• Strong organizational skills.
  
• Strong microbial background and in depth knowledge of cleaning / sanitizing agent and their impact on process, equipment and consumables
  
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional requirements and balance competing priorities effectively.
  
• Cleaning agent risk assessment and cleaning efficacy studies
  
• 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
• 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.