Director of External Manufacturing Quality

<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><p> </p> <div class="col-xs-12 no-horiz-padding"> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking a <strong>Director of External Manufacturing Quality</strong> as part of the <strong>Quality </strong>team based in <strong>Somerset, NJ. </strong></span></p> <p> </p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p class="drawer-body-p"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">The Director of External Manufacturing Quality will be responsible for overseeing external manufacturers in support of the Legend clinical pipeline for cell therapy drug substance and drug product manufacturing. This role will provide quality oversight and ensure external sites operate in full compliance with established cGMP clinical requirements. This individual will be a key leader in the US Operations organization and a champion for quality principles and compliance. The role develops and implements long-term quality strategies for the transfer and execution of the Legend clinical products. This role will also manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities. The Director will collaborate with cross-functional and external counterparts to develop and establish compliance requirements for external partners manufacturing Legend pipeline products. </span></p> <p> </p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong> </span></p> <ul> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Serves as the External Manufacturing Quality Lead in support of cell therapy pipeline manufacturing operations at Contract Manufacturing Organization (CMOs).</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Provide leadership and oversee the Quality functions (Quality Assurance, Quality Systems, Quality Control) of external CMOs.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and cell therapy products.</span></li> <li style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;" ... (truncated, view full listing at source)