Associate Director, Global Strategy & Investigations Owner/Lead
Raritan, NJ, United States
Legend Biotech is seeking Associate Director, Global Strategy & Investigations Owner/Lead as part of the Technical Operations team based in Raritan, New Jersey.
Role Overview
This position is a key member in the global MSAT organization leadership team. This individual will beresponsible for a global operational strategy and investigations 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 strategic operations to ensure that available and future capacity can meet forecasted demand. Strategic planning is required to identify and implement operationalimprovements, capacity expansion/optimization, cost of goods / non-conformance reduction and improved turnaround times worldwide. Additional responsibilities will be providing technical content/strategics plans as part of collaborative working groups with cross functional partners (i.e. and competitiveness) to develop process automation and improve delivery/logistics topatient (i.e.. reduce TAT) allowing Legend to maintain a competitive advantage in the market place.
Key Responsibilities
Additional responsibilities include;
Provide technical leadership and support to an expanding global manufacturing network for best-in-class CAR-T product.
Management oversight and/or contribute to strategic capacity plans/COGsreduction/TAT/OOS reduction, global investigations, global metrics reporting and systems.
Co-Facilitates complex global investigation with partner. Drives plans to recommend and implement improvements and ensures continuity amongst sites and external CMO partners.
Drives plans for existing and future facility infrastructure and determines optimal approaches for which to maximize utilization and capacity to meet global demand.
Drives and prioritizes operations improvements (closed process, streamlined operations), collaborates on new automation technology platforms.
Develops Data Analytics & Global Reporting structure and identifies appropriate business systems and tools to ensure effective reporting across sites and external CMO partners.
Collaborates and ensures alignment with key cross-functional stakeholders and partners (i.e.supply chain, quality, alliance mgmt., finance, operations, MFG leadership and commercial).
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 operations with end-to-end know-how to drive changes/improvements and capacity plansin a global manufacturing network.
Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
Experience in a cross functional commercial team in driving global programs and/or initiatives.
Experience in implementing and managing commercial process improvements and changes and leading complex investigations.
Experience in driving consistency across multiple manufacturing sites.
Extensive knowledge in cell therapy operations, technology transfer, investigations, capacity/throughput studies, strategic capacity upgrades.
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 multiplepartners 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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