Location: Raritan,NJ, USA
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 Technician as part of the Quality Operations team based in Raritan, NJ.
Company Introduction
From the very beginning, we've been focused on the science. We came together as a team of experts, committed to quality, driven by excellence, and dedicated to experimentation. Though we faced many challenges, we remained fearless in our research and rigorous in our thinking, pushing ourselves to work harder. But what impacted us the most was the enormous burden patients' bear and the difficulties they face, which drove us to think about what's next.
We believe it's time to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused on CAR-T in multiple myeloma, we firmly believe the prospects of cellular therapy stretch beyond just one disease or indication. The spark of hope is lit. At Legend Biotech, we're using that hope to ignite the future of CAR-T cell therapy.
Strategic Collaboration
Legend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.
Role Overview
The QC Technician is responsible for QC sample labelling process. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively.
Key Responsibilities
* Prepare and print labels.
* Reconcile QC label reconciliation forms independently.
* Responsible for managing QC sample labeling process for each batch.
* Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
* Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)and lab management software system (LIMS)
* Sample Runner for the laboratory
* Responsible for laboratory clean ups.
* Supports internal and regulatory audits.
* Any other task assigned by management.
Requirements
* A minimum of an Associate degree in science or related field
* A minimum of one (1) year related experience in medical device, biopharmaceutical, or pharmaceutical industry
* Must be able to work 2nd shift, 4PM-2:30AM
* Good understanding of regulatory requirements, policies and guidelines
* Working knowledge of Quality systems
* Experience in use of eLIMS or similar systems.
* Position shift schedule will be 4 days (10 hours/day) Sunday-Wednesday or Wednesday to Saturday.
* This position will be located in Raritan, NJ and may require up to 5% of travel
* This position will occasionally require to lift up to 10 pounds
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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.