Manager, Patient Cell Operations

POSITION SUMMARY: 

The Manager of Patient Cell Operations will serve as a key member of Patient Operations in the Supply Chain organization. This individual will be responsible for managing all operations regarding the collection and management of patient cells during the cell therapy process. This cross-functional role will work with manufacturing, clinical operations, quality, CMC and external clinical sites to ensure right first-time management of patient cells (apheresis, tissue, and final drug product) related to the manufacturing process. 

To be successful in this role, this person will need to be self-motivated, have a high attention to detail, and be eager to establish clear process and procedures for the Patient Cell Operations team. This person will need to be able to accept flexibility in their day-to-day responsibilities; in addition to supporting cell handling during collections and drug product receipt/administration, they will also need to be forward thinking to eventually grow and establish a team. 

 KEY ROLE AND RESPONSIBILITIES: 

• Create, manage, and maintain controlled manuals that describe the process for apheresis collection and final drug product administration. 
• Ensure right first-time apheresis and final drug product handling at the clinical sites and apheresis centers. 
• Establish and maintain training material related to the Patient Cell Operations controlled manuals.
• Ensure any persons at the clinical site and apheresis center managing Patient Cells are appropriately trained. 
• Manage Lyell healthy donor apheresis suppliers. 
• Own any CAPAs or Deviations related to improper handling of patient cells.
• Work collaboratively and partner with Manufacturing, Quality, Clinical Operations, CMC, Research and Development, and with any Lyell partners or contracted organizations/services.   
• Ensure appropriate materials or shipping containers required for handling patient cells during collection or final drug product are validated. 
• Responsible for managing the forecast of clinical site dry runs to ensure appropriate communication with the manufacturing teams. 
• Establish electronic tools, processes, and procedures to support the Patient cell operations team. 

 PREFERRED EDUCATION & EXPERIENCE: 

• Bachelor’s Degree and 3+ years relevant work experience; or sufficient work experience in related field for 7+ years.
• Cell Therapy experience in patient cell operations or apheresis operations 
• Clinical/Nursing experience related to apheresis, tissue collections, and/or infusions 
• Experience managing cross functional relationships with several different teams internally in the company and externally 
• Experience working and creating documents in a GxP environment