Job Description
<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three RD sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.</span></p>
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<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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). 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.</span></p>
<p style="line-height: 1.2;"> </p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking an <strong>Investigator I/II</strong><strong> </strong>as part of the <strong>Technical Operations </strong>team based in <strong>Raritan, NJ</strong>.</span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The CAR-T Investigator will be part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will also oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.</span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong></span></p>
<ul>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Lead manufacturing and cross functional investigations from end to end.</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination.</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work cross functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and ensuring compliance.</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections.</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure investigations are processing timely according to site specified requirements.</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving.</span></li>
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