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Legend Biotech is seeking Executive Director, Pipeline CMC Technical and Strategic Lead as part of the Technical Development team based in Somerset, NJ. 

Role Overview

The Executive Director, Pipeline CMC Technical and Strategic Lead will be responsible for formulating and delivering the technical CMC components of cell therapies and related novel treatment modalities in a robust pipeline aimed at changing the course of medicine.  He/she will maximize the value of company assets by accelerating timelines, defining unknowns, implementing calculated risk taking, ensuring phase-appropriate compliance, and leading excellent execution.  The successful candidate will work closely within the technical teams to ensure on-time execution and adaptation to dynamic development priorities.  The position demands strong technical, pragmatic, and strategic CMC leadership within a collaborative, science-based, and patient-focused environment.

Key Responsibilities  

• Lead empowered technical teams to create and refine the CMC approaches for rapidly delivering phase-appropriate process, analytical, and gene editing components of projects with scientific excellence and patient-focus
• Develop a vision for commercial line of sight for each product, including staging of process/analytical updates, comparability strategies, cost analyses, and technology integration
• Direct the integration of process development, analytical development, and gene editing strategies for each pipeline project within technical development and with related functions
• Ensure excellence in execution of CMC components of projects
• Communicate the potential for issues and delays along with solutions and mitigation approaches
• Direct the maintenance of a seamless relationship with research organizations and partners across the globe
• Creatively maximize quality, efficiency, and timeline for pipeline projects while defining unknowns
• In collaboration with the CMC Project Manager, Project Leader, and other technical leads, identify project acceleration opportunities
• Identify relevant cross functional dependencies and constraints and work to facilitate timely resolution to achieve the desired outcomes
• Ensure sufficient resource availability to deliver pipeline programs on time, including adjusting assignments to accommodate shifting demand
• Direct the collaboration with in-house manufacturing to start up and operate the facility
• Enable effective and rapid decision making with clear risks, mitigations, go/no-go criteria, and assumptions
• Support the advancement of each project through governance endorsement at each stage-gate review
• Maintain strong awareness of competitive landscape and adapt project approaches to maintain best/first in class
• Establish an empowered, collaborative, science-based, agile, innovative, continuous improvement, and patient-focused culture
• Function as a single point of accountability for CMC process, analytical and gene-editing contributions to each project
• Build strong collaborative relationships among functional areas and create a culture of transparency, unity and engagement
• Resolve conflict and proactively identify performance issues detrimental to the team and organization
• Direct troubleshooting technical issues in manufacturing and quality control for clinical product supply
• In collaboration with the innovation lead, foster creativity and continuous improvement via new innovations to deliver differentiation and superiority of our cell therapy products
• Build science-focused high-performing teams to address development and manufacturing requirements for cell therapy products in development
• Direct the support of technical components of CMC sections of regulatory submissions
• Ensure compliance with regulatory requirements
• Direct the creation and execution of strong employee development plans enabling staff readiness for future challenges delivering impactful technologies to patients

Requirements

•  Advanced degree (MS, PhD) in biology, biomedical engineering, or equivalent with 15 years of applied technical experience and demonstrated leadership in a supervisory role
• 15+ years of experience with process/analytical development, manufacturing and/or QC in a biotech, academic, or pharmaceutical setting
• Extensive experience establishing manufacturing processes and QC assays to supply clinical trials for autologous and/or allogeneic clinical trials
• Deep technical expertise in cell therapy processes and assays
• Experience with gene editing processes and analytics is a strong plus
• Excellent leadership, emotional intelligence, and communication skills
• Experience with viral vectors is a plus
• Demonstrated proficiency preparing regulatory submissions
• Proven track record of advancing cell therapies into first in human and late-stage clinical trials
• Creative, strategic thinking
• Composure during challenging times
• Strong troubleshooting skills
• Language(s):English. Mandarin is a plus.

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