Scott Waniger

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

Experience

1. Senior Project Manager

   Atyr Pharma

   Mar 2025 — Present

   Oversight of CMC activities at a large North American based CDMO to support validation of commercial scale DS & DP manufacturing for a therapeutic fusion protein.

Education

• University of Wisconsin-Stevens Point

  BS, Medical Technology

  1981 — 1985

Skills

• Antibodies
• Medical Devices
• Cell Culture
• Analytical Chemistry
• Biopharmaceuticals
• Validation
• Assay Development
• Biotechnology
• 21 Cfr Part 11
• Sop
• Fda
• Life Sciences
• Glp
• Technology Transfer
• Biochemistry
• Purification
• Biologics
• Gmp