Senior Director, Manufacturing

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. The Senior Director of Manufacturing leads our cell therapy manufacturing organization through the transition from clinical-stage to commercial operations. The Senior Director owns GMP manufacturing execution across the product lifecycle, including facility and process readiness for BLA submission and pre-license inspection (PLI), and the build of a scalable, inspection-ready commercial manufacturing organization. This is a hands-on leadership role for someone who has taken an autologous cell therapy through late-stage clinical manufacturing and into licensure and launch. KEY ROLE AND RESPONSIBILITIES: Commercial Readiness and Launch • Lead manufacturing readiness for BLA filing, PLI, and commercial launch, including facility qualification, process performance qualification (PPQ), and technology transfer from Process Development. • Develop and execute the manufacturing strategy, including capacity planning and site expansion. • Partner with Supply Chain, Quality, and Commercial to ensure reliable vein-to-vein performance, including turnaround time, slot scheduling, and patient-specific logistics. GMP Manufacturing Operations • Direct day-to-day clinical and commercial manufacturing, ensuring compliance with cGMP, 21 CFR Parts 210/211, 600-680, and 1271, and applicable EU/ICH requirements. • Drive right-first-time execution, batch record quality, and on-time batch disposition. • Own deviations, CAPAs, and change controls arising from manufacturing, partnering closely with Quality Assurance on root cause and effectiveness. • Maintain a continuous state of inspection readiness and serve as a senior representative during regulatory and partner audits. • Strong scientific background and expertise in cell culture products - prior experience in cell or tissue therapy • Demonstrated experience in process characterization and product development, technology transfer, continuous improvement and change management Process Robustness and Continuous Improvement • Partner with Process Development and MSAT to ensure process transfer, scale-up, comparability, and lifecycle management. • Lead manufacturing success rate, cost of goods (COGS), and cycle-time improvement through lean/operational excellence methods. • Evaluate and implement automation, closed-system proc