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Legend Biotech

Global Viral Vector MSAT Lead

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What they do

A Director of Manufacturing oversees management of all areas of manufacturing to produce products and direct activities so that approved products are manufactured on schedule and within quality standards and cost objectives.

$181,348 / year median in New Jersey

+6% projected growth

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Job Description

Job Details 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 D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. 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. Legend Biotech is seeking a Global Viral Vector MSAT Lead as part of the Global Manufacturing & Supply team based in Raritan, NJ. Role Overview 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. Key Responsibilities Lead MSAT technical support for clinical and late-stage GMP manufacturing of viral vectors for in vivo platforms. Own end-to-end process knowledge for assigned viral vector platforms, including upstream production, downstream purification, formulation, and fill/finish interfaces. Lead technology transfer of viral vector processes from Process Development into GMP manufacturing, including internal sites and external CDMOs. Serve as the primary MSAT technical lead for deviations, root cause investigations, risk assessments, and CAPA execution. Drive process characterization, control strategy development, continued process verification (CPV), and performance trending. Partner cross-functionally to identify and mitigate manufacturing, scale-up, and comparability risks to ensure supply continuity. Provide MSAT technical input to CMC regulatory submissions, health authority interactions, and inspection readiness. Lead, mentor, and develop a team of MSAT scientists and engineers. Drives justification and alignment with key partners (ie. JnJ). Requirements B.S. required, in technical discipline: biology, engineering, science, or related field. Minimum 10 years of in MSAT, tech transfer or process development. Industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. 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. Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT. Experience in a cross functional CMC team as a technical representative driving global commercial programs in cell therapy. Experience as a technical owner in reviewing regulatory submission sections, responding to agency audits. Experience in implementing and managing new commercial processes, improvements and changes. Experience in driving consistency across multiple manufacturing sites. Experience in collaborating with external partners and CMOs preferred. Extensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations support. Ability to think critically and demonstrated troubleshooting and problem-solving skills. Results driven with strong analytical, problem solving and critical thinking skills. Strong experience working in a cross-functional organization with multiple partners with competing priorities. Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation. #Li-BZ1 #Li-Hybrid Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. Work Authorization & Employment Eligibility Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates. EEO Statement 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. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. For information related to our privacy notice, please review: Legend Biotech Privacy Notice . Company Legend Biotech was founded as an early-stage cell therapy company in 2014. The company was the brainchild of visionary scientists who recognized that antibody-based therapeutics could potentially treat disease and possessed the backgrounds in immunology and gene editing to take the leap. For two years, Legend Biotech, then known as the "Legend Project," operated in a room the size of a freight elevator, with the goal of creating a cell therapy for multiple myeloma, a hematological cancer that often relapses and can become refractory. The team produced nanobodies for single-domain antibody drugs and ultimately extended the half-life of the nanobodies with proprietary technologies. In 2015, Legend's scientists focused on research for chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein, making the biotech one of the first companies in the world to engineer CAR-T cells for the BCMA protein. In 2016, investigator-initiated trials began in China. In 2017, data from the trials were presented at the American Society for Clinical Oncology (ASCO), which led to a partnership with biopharmaceutical company Janssen Biotech, Inc. to co-develop the anti-BCMA CAR-T, ciltacabtagene autoleucel (cilta-cel). Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world.
CARVYKTI
™ (ciltacabtagene autoleucel) was approved by the U.S. Food and Drug Administration in February 2022 and received conditional marketing approval from the European Medicines Agency in May 2022. Today Legend Biotech is a global, commercial-stage company driven by a passion for patients. We continue to build our pipeline of cell therapy platforms, which includes CAR-T, CAR-NK, CAR-γδ T and non-gene-editing CAR technologies. Our goal is to bring hope and opportunity to patients and their families by continuing to explore unique technologies. Company info Location Somerset New Jersey US