James Curtis Email and Phone Number

Engaged as Business Process Owner for the Manage Logistics workstream on Kite’s ERP transition Serves as a member of the TCF05 Supply Chain Leadership TeamConsults regularly with Quality, Manufacturing, and Global Supply Chain on network vein-to-vein operations

Led qualification and operational readiness of warehouse and material management activitiesDeveloped and implemented cGMP compliant processes and protocols to support cell therapy operations Created staffing models to ensure appropriate staffing to meet capacity requirementsImplemented training curricula to meeting cGMP and EHS requirementsAided in the development of the TCF05 Business Continuity Plan and subsequent testingLiaised with Manufacturing and Process Development in the technical transfer of Yescarta to TCF05Engaged with Quality, Planning, Manufacturing, and Logistics to ensure TCF05 project goals were metDelivered relevant departmental input and assessments for change controls, investigations, and deviationsAssisted in budget development and adherence to the approved budget

Assisted Project Director in strategic planning to meet Level of Effort contract requirements (labor allocation, personnel screening and hiring, capital expenditure, vendor management)Acquired/maintained federal import/export/transportation permits for BSL 2 materials and clinical agentsAuthored monthly report to NIH, DMID, Contracting Officer’s Representative per contract terms

Commissioned a 44,000 ft2 cell therapy drug distribution facility (The CryoCentre) in Frederick, MDExecuted Change Controls for the CryoCentre facility and equipment qualification, on-boarding of new equipment, and FMEA remediationGenerated documentation and Standard Operating Procedures to meet the CryoCentre facility purposeManaged Operations’ responsibilities for the relocation of cell therapy storage units and product from Rockville, MD to the CryoCentre facility in Frederick, MDProvided Change Control management, Risk Assessment, Failure Mode Effects Analysis (FMEA), and logistics support for the closure of a Maryland Fisher BioServices facilityCommissioned a 10,000 ft2 biorepository in Germantown, Maryland.Generated documentation and Standard Operating Procedures to meet facility purpose

Led a diverse team of technicians in distributing cell therapy drug in phases 1, 2, and 3 of clinical trialsDesigned training requirements and oversees performance reviews for direct reportsUtilized ERP systems to meet or exceed client expectations and maintain accurate inventoriesPrimary point of escalation for all issues related to LN2 distribution and LN2 material/product storageCollaborated with project managers, clients, and QA to author SOPs, SWIs, CWIs, and batch recordsManaged deviations, complaints, CAPAs, and change controls utilizing TrackWise (EQMS)Worked with the Validations department to qualify all equipment as requiredPartnered with vendors to ensure timely delivery of equipment, materials, and servicesOperations Leader for the commissioning of a cell therapy distribution facility in Tokyo, JapanOperations SME at a 3P event planning the CryoCentre

Engaged with clients as the Operations Supervisor/PM for projects at the Washington Avenue repositoryConducted regular invoicing, scheduling of client requests, and all onsite tours Maintained facility systems; generators, alarm system, and security system in collaboration with vendorsLed successful installation of a 1600 sq. ft. -45°C walk-in freezer from design to completion

Delivered consistent high-quality inventory management and systems data inputsExecuted high performance cold chain distribution and receiving operations according to cGMPs