Thomas Eunson Email & Phone Number

Madison, Wisconsin, United States

Portsmouth, Nh

Therapuetic Products Program @ Cell Processing Facility

Focus is on Facility and Technical Operations:•Investigator Oversight Committee appointed cell therapy specialist tasked with providing real-time technical support to Cell Processing Facility Production Associates and Supervisors during daily manufacturing operations in gene and cell therapy clinical trials•Lead troubleshooting investigations with production associates during unexpected cell culture observations/operations •Monitor all manufacturing operations to ensure compliance to production batch records (PBR) and standard operating procedures (SOP)•Mentor supervisors to assure investigators that all process operations are conducted adhering to their approved PBRs and SOPs•Insure all critical in-process samples are transferred promptly and without delay to our Quality Control (QC) group for product-release testing•Collaborate on critical revisions to Batch Record, SOPs and Formulation Records•Interface with Process Engineering (PE) and Process Development (PD) to assist with process optimizations and implementation of new technologies•Review and respond to all process deviation reports for potential product impact•Collaborate with Quality Assurance (QA) on all investigations related to processing deviations for root cause analysis and the identification of necessary corrective and preventative action (CAPA).•Track and update all cellular manufacturing data and use trending results to modify the current cell processing procedure, in collaboration with PD and PE, in order to manufacture a more consistent clinical product from subject run to subject run.

Cell Processing Facility

• Direct supervision of 10 staff performing clinical trial manufacturing for gene and cell therapy • Hire and train, using our modified Training Module approach, production associates• Schedule and assign proper staffing to all cell processing procedures• Act as a primary point of contact with investigators/sponsors – informing them manufacturing readiness and execution, reporting out current production run status as well as production run data summary

Cell Processing Facility

• Direct monitoring of cell production staff during clinical production runs for investigator protocols• Onboard and train new associates using our new staff training process• Review completed production runs with investigators and process engineering to provide direction for investigations and process improvements

Cell Processing Facility

• Roll out systems and equipment SOPs for new class 10000 (ISO 7) cGMP facility• Assisted in coordinating the onboarding of six large cell therapy IND protocols and the laboratory testing requirements with numerous time-sensitive milestones for five-plus years. Duties included: coordinating and tracking clinical trials production and cellular characterization testing by flow cytometry; established product safety procedures; oversaw testing process; handled regulatory compliance, streamline procedures, process improvements, documentation, and recordkeeping• Compile run summary data and prepare reports for presentation to investigators

Greater Seattle Area

Division of Hematology at UW Medical Center