Quality Control Manager

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. Position Summary: We are seeking a highly motivated QC Manager – Cell Therapy to join our dynamic and high-performing team at the Lyell Manufacturing Facility (LyFE) in Bothell, WA. The QC Manager will be responsible for leading Quality Control operations supporting GMP manufacturing, release of cell therapy products, and the transfer of analytical methods to the site. This role oversees analytical testing and data review, environmental monitoring, laboratory compliance, data integrity, and method lifecycle management to ensure products meet regulatory, safety, and quality standards. The QC Manager ensures adherence to cGMP, regulatory guidance, and internal quality systems while supporting clinical and commercial manufacturing. The ideal candidate will have experience in a GMP-regulated facility with a good technical foundation in one or more of the following assays required for release testing of cell therapy products: cell-based potency, flow cytometry-based, or PCR-based. This is an onsite role with no remote work option. Key Responsibilities: • Schedule day-to-day QC laboratory operations supporting release and in-process testing of cell therapy products. • Oversee method lifecycle for analytical assays such as flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays. • Perform data review to support drug product Certificate of Analysis issuance. • Manage the Contamination Control Program for the manufacturing site. • Ensure timely testing and release of raw materials and drug product. • Support method transfer, qualification, validation, and lifecycle management of analytical methods. • Manage, mentor, and develop QC analysts and supervisors. • Establish staffing plans and training programs to support laboratory operations. • Review and approve analytical records, certificates of analysis, and laboratory documentation. • Ensure proper maintenance and qualification of laboratory equipment. Experience with BMRAM is a plus. • Oversee stability testing programs. • Partner with Manufacturing, QA, Regulatory, Process and Analytical Development, Manufacturing Sciences and Technology, and Supply Chain to support product release and continuous improvement. • Initiate, lead, and partic