XCELLEREX INC 2002 - Present Contract Manufacturing and Systems Development General Manager, Engineering Operations – - Built Manufacturing team to 50 person, $6 Million revenue organization in 4+ years - 1000L mammalian cell culture manufacturing suites brought online for non-GMP and GMP manufacturing services – covers culture initiation to bulk fill operation - 250L bacterial fermentation manufacturing suite brought online for GMP services – covers culture initiation to bulk fill operation - Materials management and warehouse systems implemented to support manufacturing – controlled temperature storage, material, personnel and product flow - Facility design, preventive maintenance, and metrology programs implemented - Hired staff for manufacturing, facility, IT and support functions - Specified and installed automation tools for Quality Assurance functions, including a web-based EDMS (electronic document management system), CAPA, Training and electronic forms tools - Presented company operations to FDA for technology discussion meeting, completed follow-up training seminar for FDA inspectors - Company startup activities: Completed site selection, installed basic services, lease, equipment installation and commissioning for clinical manufacturing (mammalian and bacterial), laboratories, and services Systems Development- - Launched single use bioreactor and mixer products to market, generated $1.5 Million in revenue 2007, projected to 8-10 Million 2008 - Design, construct and test disposable bioreactor systems for mammalian cell culture, using integrated components including disposable reactor, impellor, sensors, data acquisition and control systems - Design and test additional disposable systems for mixing and recovery unit operations - Installed Information Technology infrastructure to support business operations in addition to data storage, MES platform (e-batch records, data acquisition, supply chain and finance)
