Director of CMC Innovation

Role Overview

The Director of Next Generation Cell and Gene Therapy Processes (CMC Innovation) will be at the forefront of advancing cell therapy manufacturing by driving innovative process development. This role will focus on enhancing process efficiency, scalability, and robustness through the identification, proof of concept, development, and integration of novel process solutions. The successful candidate will lead internal initiatives and strategic collaborations and partnerships with innovation provider partners to spearhead the realization of these advancements. They will also develop business cases to prioritize opportunities that improve patient access by enhancing cost efficiency, product quality, manufacturing speed, and scalability. In close collaboration with cross-functional teams, the Director will oversee the implementation of these strategies across multiple products, ensuring alignment with regulatory and technological advancements.

Key Responsibilities

• Identify and prioritize challenges in manufacturing process for autologous, allogeneic, gene-editing, or viral vector platforms, and address them with innovative solutions.
• Scout, evaluate, and implement emerging process technologies to enhance manufacturing efficiency, product consistency, and cost-effectiveness.
• Develop and socialize balanced comparisons of emerging process technologies using suitability matrix tools to support data-driven decision-making.
• Develop business cases to guide decision-making and prioritize process innovations based on impact, feasibility, investment, and regulatory considerations.
• Optimize process development strategies to accelerate manufacturing timelines while ensuring product quality and regulatory compliance.
• Establish proof-of-concept studies for novel technologies, demonstrating their potential to improve scalability, robustness, and efficiency in manufacturing.
• Assess the feasibility of implementing new technologies across Legend's product portfolio and define a roadmap for their integration.
• Lead the design and implementation of next-generation manufacturing platforms, including automated and closed-system processing technologies.
• Develop strategic implementation plans, including timelines, cost projections, risk assessments, and regulatory strategies for process innovation initiatives.
• Drive technology transfer strategies to seamlessly integrate novel process developments into clinical and commercial manufacturing operations.
• Collaborate with business development and external partners to identify and establish relationships with key technology providers, providing technical insights to assess potential collaborations and weigh in on agreements to ensure alignment with innovation and manufacturing goals.
• Stay at the forefront of process development innovation by monitoring industry trends, literature, conferences, patents, and emerging companies.
• Cultivate strong cross-functional relationships, promoting transparency, collaboration, and knowledge-sharing to advance process innovation goals.
• Provide strategic direction and subject matter expertise on process development technologies, ensuring a smooth transition from innovation to implementation.
• Support regulatory submissions by providing technical documentation on implemented process innovations.
• Deep knowledge of process comparability strategies to ensure seamless transitions between development stages, scale-up, and manufacturing site changes while maintaining product quality and regulatory alignment.

Requirements

• B.S., M.S., or Ph.D. in Biology, Biomedical Engineering, or a related field with 8 years of applied technical experience.
• 8 years of experience in process development with exposure to manufacturing and/or quality control in cell therapy or biologics.
• Extensive expertise in cell and gene therapy process development and manufacturing.
• Strong understanding of gene-editing and viral vector-based processes is a plus.
• Experience with automation, closed-system processing, and other advanced manufacturing technologies is a plus, particularly in evaluating, implementing, and optimizing these innovations for improved efficiency, scalability, and compliance.
• Strategic thinker with a demonstrated ability to develop and implement process innovations.
• Excellent leadership, communication, and collaboration skills with a high degree of emotional intelligence.
• Proven track record of successfully managing cross-functional projects and leading technical teams.
• English required; Mandarin is a plus.

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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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