Global Viral Vector MSAT Lead at Legend Biotech

<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 R&amp;D 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;">&nbsp;</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 &amp; 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;">&nbsp;</p></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is seeking a <strong>Global Viral Vector MSAT Lead</strong> as part of the <strong>Global Manufacturing &amp; Supply</strong> team based in <strong>Raritan, NJ.&nbsp;</strong></span></p> <p>&nbsp;</p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Role Overview</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Senior Manager, MSAT – Viral Vector Lead for global In Vivo platforms provides technical leadership and execution oversight for viral vector manufacturing supporting in vivo programs across clinical development and commercial lifecycle management. This role ensures robust, scalable, and compliant manufacturing processes for viral vector platforms that can be transferred to internal or external sites. This role requires collaboration and partnering closely with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain teams to enable reliable clinical supply and future commercialization.</span></p> <p>&nbsp;</p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead MSAT technical support for clinical and late-stage GMP manufacturing of viral vectors for in vivo platforms.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Own end-to-end process knowledge for assigned viral vector platforms, including upstream production, downstream purification, formulation, and fill/finish interfaces.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead technology transfer of viral vector processes from Process Development into GMP manufacturing, including internal sites and external CDMOs.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Serve as the primary MSAT technical lead for deviations, root cause investigations, risk assessments, and CAPA execution.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drive process characterization, control strategy development, continued process verification (CPV), and performance trending.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Partner cross-functionally to identify and mitigate manufacturing, scale-up, and comparability risks to ensure supply continuity.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide MSAT technical input to CMC regulatory submissions, health authority interactions, and inspection readiness.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead, mentor, and develop a team of MSAT scientists and engineers.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drives justification and alignment with key partners (ie. JnJ).</span></li> </ul> <p>&nbsp;</p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Requirements</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">B.S. required, in technical discipline: biology, engineering, science, or related field.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Minimum 10 years of in MSAT, tech transfer or process development.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience in cell therapy commercial cGMP program with end-to-end know-how to manage process platform changes/improvements in a global manufacturing network and change management process.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience in a cross functional CMC team as a technical representative driving global commercial programs in cell therapy.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience as a technical owner in reviewing regulatory submission sections, responding to agency audits.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience in implementing and managing new commercial processes, improvements and changes.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience in driving consistency across multiple manufacturing sites.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience in collaborating with external partners and CMOs preferred.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Extensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations support.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to think critically and demonstrated troubleshooting and problem-solving skills.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Results driven with strong analytical, problem solving and critical thinking skills.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong experience working in a cross-functional organization with multiple partners with competing priorities.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation.</span></li> </ul> <p>&nbsp;</p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-BZ1</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-Hybrid</span></p><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.</strong></span></p> <p>&nbsp;</p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>EEO Statement</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.</span></p> <p style="line-height: 1.2;">&nbsp;</p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.</span></p> <div>&nbsp;</div> <div><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">For information related to our privacy notice, please review:&nbsp;<a href="https://legendbiotech.com/privacy-notice/" target="_blank">Legend Biotech Privacy Notice</a>.</span></div></div>