Patient Cell Operations Manager - Contract

Patient Cell Operations Manager - Contract Manufacturing Bothell, Washington, United States; Seattle, Washington, United States Lyell is seeking an experienced contractor to perform the Patient Cell Operations management function within the Supply Chain organization, reporting to the Supply Chain leadership. The contractor will lead the day-to-day operational management of patient cells across the cell‑therapy lifecycle, including apheresis, tissue collection, and final drug product handling. This is a highly cross‑functional role that works closely with Manufacturing, Clinical Operations, Quality, and external clinical sites and apheresis centers to deliver right‑first‑time execution of patient cell handling processes that support manufacturing and clinical trial success. As a contractor, the individual will run and coordinate these processes day‑to‑day. The individual executes, manages, and drives the work under the direction of the Supply Chain leadership, escalating decisions when required. To be successful, the individual must be self‑motivated, detail‑oriented, and able to operate effectively in a dynamic environment, bringing forward‑thinking leadership to help establish scalable processes, procedures, and training frameworks that support the growth of the Patient Cell Operations team. Patient Cell Operations Execution Create, manage, and maintain controlled manuals describing processes for apheresis collection and final drug product administration. Drive right‑first‑time apheresis and final drug product handling at clinical sites and apheresis centers. Manage day‑to‑day relationships with Lyell healthy donor apheresis suppliers. Manage CAPAs and deviations related to improper handling of patient cells, partnering with Lyell process owners for final disposition and approval. Partner cross‑functionally with Manufacturing, Quality, Clinical Operations, and external vendors and service providers. Ensure materials and shipping containers required for patient cell collection, transport, and final drug product handling are properly validated. Establish and continuously improve electronic tools, processes, and procedures that support Patient Cell Operations activities. Clinical Site Readiness & Training Lead the execution of training for clinical sites and apheresis centers on the Apheresis Manual and Drug Product Administration Manual, supporting procedural compliance and operational excellence. Develop, deliver, and routinely update training programs to reflect evolving operational practices, regulatory requirements, and feedback from clinical and apheresis sites. Manage clinical site onboarding and requalification through structured training, documentation review, mock runs, and site readiness assessments. Ensure all personnel involved in patient cell handling are appropriately trained, qualified, and documented in accordance with GxP requirements. Demonstrated experience managing operations in cell therapy, biologics, supply chain, or clinical operations within a GxP‑regulated environment. Proven ability to own day‑to‑day execution of complex, cross‑functional processes and deliver right‑first‑time results. Strong command of controlled documents, CAPAs, deviations, and training frameworks. Excellent cross‑functional collaboration skills and experience managing external partners, clinical sites, and vendors. Self‑motivated leader who operates effectively and decisively in a fast‑paced, dynamic setting. Experience with Cell Orchestration Platforms a plus. BA/BSc with a minimum of 10 years’ experience; or MBA or MSc with a minimum of 7 years’ experience At least 5 years management experience in patient cell operations This is a contract position. Compensation is commensurate with experience and will be discussed during the interview process. The hourly rate of pay is between $85.00 - 95.00 per hour #J-18808-Ljbffr