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QC Microbiology Technical Specialist I/II/III

Raritan, 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 QC Microbiology Technical Specialist I/II/III as part of the Quality team based in Raritan, NJ. 

Role Overview

The QC Microbiology Technical Specialist is an exempt level position with responsibilities for tracking and managing all CAPA’s, corrections and change controls, developing microbiology procedures and methods, ownership of various QC Microbiology department projects, supporting laboratory investigations, and support and track all process improvement projects.

Key Responsibilities  

  • Support all quality system records (i.e. CAPA’s and change controls) to ensure records are implemented and closed in a timely manner.
  • Support investigations of laboratory non-conformances (events, test plans/summary reports, deviations, and invalid assays).
  • Implement changes as part of process improvement initiatives, to meet regulatory requirements, etc.
  • Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
  • Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Other duties will be assigned, as necessary
  • Key Relationships:
    • Work in a collaborative setting with quality counterparts that include quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
      - Job Duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
      - Distance visual activity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 or better with corrective lenses.

Requirements

  • A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
  • A minimum of 4 years relevant experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy.
  • Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development preferred
  • Experience working with Quality systems is required
  • Experience with quality support in clinical manufacture or NPI is preferred.
  • Extensive knowledge of chemical, biochemical, and microbiological concepts is required.
  • Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
  • Knowledge of cGMP regulations and FDA/EU guidance if required.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  • Comfortable with speaking and interacting with inspectors.
  • Good written and verbal communication skills are required.
  • This position may require occasional travel to partner sites in NJ or PA as business demands.
  • Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
  • This position may require up to 10% domestic or international travel as business demands.
  • Language: English

#Li-Onsite

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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.

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