Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences

<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> <p style="line-height: 1.2;"> </p> <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><div class="col-xs-12 no-horiz-padding"><hr> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking <strong>Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences </strong>as part of the <strong>Technical Development </strong>team based in <strong>Somerset, NJ. </strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Sr. Advanced Analyst, Clinical QC Operations and Sciences will be responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell and gene therapy pipeline assets to patients in need. The successful candidate will collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate quality control laboratory for the purpose of producing Phase 1 products. The following activities will include implementing testing and release for cell and gene therapy product candidates. Additionally, the successful candidate will lead quality control testing, complex investigations, and coordinate with external parties for testing</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;">Create and author laboratory test methods and additional procedures necessary to operate a quality control laboratory at Phase 1 clinical standards.</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 analytical development to perform method transfers and qualifications within the quality control laboratory.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Review and approve quality control test results, ensuring data integrity and compliance with cGMP and regulatory 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;">Troubleshoot assay performance issues and support method optimization and development.</span></ ... (truncated, view full listing at source)