Lead QC Microbiology Data Reviewer

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 Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. 

Role Overview

The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for leading a team of microbiology data reviewers supporting the reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology Data Reviewer will also be responsible for the completion of environmental monitoring trend reports.

Key Responsibilities  

• Scheduling of daily activities for direct reports.
• Completion of routine environmental monitoring trending.
• On-time completion of microbiology trend reports.
• Responsible for reviewing routine EM sampling, including viable/non-viable air and surface 
  sampling, related to Raritan manufacturing processes, either for clinical trials and 
  commercial operations in a controlled cGMP cleanroom environment.
• Create, review and approve relevant QC documents, logbooks, SOP’s and WI’s.
• Ensure microbiological control strategy is consistent with cGMP requirements. 
• Participate in training and delivery of Operations aseptic technique and microbiology 
  awareness training program. 
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring 
  program.
• Perform peer review/approval of laboratory data including endotoxin, sterility, growth 
  promotion, as well as other microbiological assays.
• Utilize electronic systems (LIMS) for execution, documentation, review of testing.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP 
  requirements.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and
  applicable pharmacopeia while remaining current in on-the-job training requirements.
• Other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor’s Degree in Science, 
  Engineering or equivalent technical discipline is 
  required. 
• 6+ years relevant work experience, 
  preferably within a biological and/or 
  pharmaceutical industry is required. 
  • Experience with microbiology testing 
  preferred.
• Extensive experience trending data
  • Experienced with completion of 
  microbiological trend reports.
  • Strong Microsoft Excel experience

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.