Scott Waniger

Background

About Scott Waniger

I have 35+ years experience manufacturing complex biologics driven by a warrior spirit, a service attitude and adding in a few fun happy hours after work with the team. Past five years accomplishments: • Built three different teams for three start-up biotech companies ranging from 3-15 personnel, to support process development, analytical development and drug product manufacturing needs (procurement, supply chain, janitorial support, manufacturing ops, facilities oversight and management). Most personnel were entry level. I spent ~1100 hours in ISO/6-8 clean rooms training, performing scale up, engineering and clinical manufacturing. • Directed five different CDMO/CRO’s remotely and by person-in-plant to perform process and analytical development, process intensification and GMP manufacturing for three different DP’s • Guided user requirement specifications for design, construction, commissioning and qualification of three manufacturing facilities ranging from sq. ft. • Lead CMC author for pIND and IND’s for IgM and three oncolytic virus platforms • Worked directly with Quality staff to bring on-line and integrate two QMS systems (Master Control and QT9). • Completed two technology transfers (oncolytic virus platform) for manufacturing and analytical needs Overview of Career Skills • Upstream: L stirred tank fed batch, 2-50 L Rocking, hollow fiber, G-Rex, roller bottle, CELLStack, HYPERFlask/Stacks, Shaker flask 0.05-10 L. Includes directing Process Development groups. Mammalian cell platforms included suspension and adherent stable cell lines in addition to transient transfection process’s • Downstream: Pro A, AEX, CEX, TFF, Nanofiltration to support upstream manufacturing batch sizes • Drug Product: IgG, IgM, autologous idiotype, oncolytic virus (three platforms) small batch vials) semi-automated fill in glovebox and ISO5/6 environments. • Quality Control: Directed Analytical development groups for oncolytic virus platforms • Aseptic Process Simulation: Designed and executed two successful APS’s for large molecules to be used in US FDA and EMA regulatory markets • Personnel Management: Extensive small company (<100 people) personnel management experience includes recruiting, training and performance reviews. • Facilities: Designed, guided construction, commissioned and qualification (EMPQ), developed User Requirement Specs for facilities, equipment, Building Automation and Monitoring systems