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 be responsible 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 operational improvements, 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 to patient (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/COGs reduction/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 plans in 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 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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