This position is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network. This individual is required to manage a global commercial program to ensure that the process platform is robust and consistent. Strategic planning is required to implement process improvements, optimization, capacity expansion, and cost of goods / non-conformance reduction efforts... more details
Company Information
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 and natural killer (NK) cell-based immunotherapy.
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) in 2017. 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 Sr. Manager / Associate Director, Global Program Owner as part of the Technical Operations team based in Somerset, New Jersey.
Role Overview
This position is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network. This individual is required to manage a global commercial program to ensure that the process platform is robust and consistent. Strategic planning is required to implement process improvements, optimization, capacity expansion, and cost of goods / non-conformance reduction efforts worldwide.
Key Responsibilities
Provide technical leadership and support to an expanding global manufacturing network for best-in-class CAR-T product.
Work collaboratively with internal and external partners to implement global process improvements/changes to increase robustness, drive down costs, ensure alignment on analytical methods and global records to realize consistent performance worldwide for both Legend and partner sites.
Provide support during Agency Inspections, filing of Submissions, and IRs.
Maintain global master batch record and documentation on the platform process and collaborate to the global change control process and global investigations.
Requirements
B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
Extensive 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 programs.
Experience as a technical owner in reviewing regulatory submission sections, responding to agency audits.
Experience in implementing and managing commercial process improvements and changes.
Experience in driving consistency across multiple manufacturing sites.
Experience in Analytical Methods Transfer preferred.
Experience in managing external partners and CMOs preferred
Extensive knowledge in process and analytical development, technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics 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.
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
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