Patient Cell Operations Manager

Job Summary

We are seeking an experienced Patient Cell Operations Manager to support the operational management of patient cells throughout the cell therapy lifecycle. This role is responsible for overseeing activities related to apheresis, tissue collection, and final drug product handling while ensuring compliant, efficient, and right-first-time execution of patient cell processes.

The position collaborates closely with Manufacturing, Clinical Operations, Quality, clinical sites, and external partners to support clinical and manufacturing programs.

Responsibilities

• Manage day-to-day patient cell operations, including apheresis, tissue collection, and final drug product handling.
• Coordinate activities with clinical sites, apheresis centers, manufacturing teams, and external suppliers.
• Develop, maintain, and update controlled documentation, operational procedures, and training materials.
• Lead site readiness, onboarding, and training initiatives.
• Manage CAPAs, deviations, investigations, and process improvement activities.
• Ensure compliance with GxP requirements, quality standards, and operational procedures.
• Partner cross-functionally with Manufacturing, Quality, Clinical Operations, and Supply Chain teams to support patient cell workflows.
• Drive continuous improvement initiatives to enhance operational effectiveness and scalability.

Qualifications

• Bachelor's degree with 10+ years of relevant experience, or Master's degree with 7+ years of relevant experience.
• Minimum 5 years of experience in Patient Cell Operations, Cell Therapy Operations, or related functions.
• Experience within cell therapy, biologics, clinical operations, or supply chain in a GxP-regulated environment.
• Strong knowledge of CAPAs, deviations, controlled documentation, training programs, and quality systems.
• Ability to manage multiple priorities in a fast-paced, highly regulated environment.