Principal, Quality Assurance

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. This role will be based out of Bothell, Washington. The Principal, Quality Assurance is responsible for providing Quality oversight and leadership across product lifecycle activities in a cell therapy environment. This role partners closely with Manufacturing, MSAT, Process Development, and Regulatory to support process implementation, technology transfer, process improvements, process validation, and commercialization efforts including regulatory submission support for submission(s). The incumbent will serve as a Quality representative on cross-functional project teams, ensuring that product-related activities are executed in compliance with GMP requirements while supporting timelines for clinical and commercial milestones. KEY ROLES AND RESPONSIBILITIES: Process Validation & Product Lifecycle Support (PPQ) for Lenti Viral Vector (LVV), Plasmids and Drug Product(s): Provide CDMO Quality oversight for process validation (PPQ) activities, ensuring execution aligns with approved protocols, GMP requirements, and regulatory expectations. Review and approve validation protocols, reports, and supporting documentation (e.g., risk assessments, sampling plans, acceptance criteria, specifications). Partner with CDMO, MSAT, and Process Development to define PPQ and validation strategies, ensuring they are robust and include evaluation of critical process parameters (CPPs), critical quality attributes (CQAs), and in-process controls. Provide Quality oversight during PPQ execution on the manufacturing floor, ensuring adherence to protocols and real-time issue escalation. Assess PPQ data for completeness, accuracy; ensure conclusions are justified and support process validation. Ensure deviations occurring during PPQ and validation are appropriately investigated, documented, and resolved with minimal impact to timelines. Ensure alignment between validation activities and regulatory filings (IND/BLA), including traceability between executed studies and submitted data. Regulatory Strategy, BLA Support & Inspection Readiness: Act as the Quality representative on cross-functional project teams supporting product development, tech transfer, process validation, IND support, and commercialization activities. Serve as Quality Subject Matter Expert (SME) for IND and BLA coordination activities, ensuring consistency between Quality documentation and regulatory submissions. Author and review CMC sections of regulatory submissions to ensure accuracy, completeness, and compliance with GM…