Peter Watler, Ph.D.
Chief Technical Officer
Industry Experience | 32 years
Prior Experience | Amgen, Hyde, VaxGen
Dr. Watler has over 32 years of biopharmaceutical process development and manufacturing experience, nearly half of which was gained in process development and manufacturing at Amgen. He is highly experienced with the development and scale-up of biopharmaceutical processes including key unit operations such as fermentation, centrifugation, filtration, and chromatography. Dr. Watler brings a strong skillset for process modeling, economic analysis, manufacturing operational excellence, process control and validation. His regulatory experience includes co-authoring two IND submissions, four BLA submissions, and participation in several FDA inspections and GMP audits.
Dr. Watler is a 12-year veteran of Amgen, which he joined in 1990. While at Amgen, he held roles leading process scale-up, manufacturing technical services and pilot plant operations. As Associate Director of Process Engineering, he oversaw the start-up of a 30,000 square foot pilot plant for monoclonal antibody development. In this role he implemented systems to accelerate technology transfer and scale up from the laboratory through to clinical production for over ten product candidates. He also led teams responsible for the process validation of Neupogen®, Stemgen®, Kepivance® and Infergen®.
Dr. Watler most recently served as Chief Technology Officer of Hyde Engineering + Consulting, Inc. He led projects for GMP manufacturing facility design where he employed state-of-the-art technologies to drive down capital costs while enhancing cGMP compliance and operational efficiency. Dr. Watler has presented extensively in the US, Canada, China, Europe and Japan on the latest ICH, FDA and ASTM approaches to pharmaceutical risk management, process validation and Quality by Design.
Dr. Watler was previously Vice President, Manufacturing at VaxGen, a Genenetech spinoff formed to develop an AIDS vaccine. He led the design, construction, and validation of a GMP facility for recombinant vaccine production. This fast-track project featured systems from top tier suppliers and went from design through construction to start-up in just 12 months. Dr. Watler was also responsible for managing supply chain and production operations, led the CMC team and prepared submissions for the FDA, NIH and DHHS. He began his career with Allelix Biopharmaceuticals as a Process Development Engineer optimizing fermentation mass transfer and product harvest operations.
Dr. Watler holds a Bachelor’s and a Master’s degree in Chemical Engineering from the University of Toronto where he developed a prototype implantable insulin pump and a Ph.D. in Chemical Engineering from Yamaguchi University, Japan where he implemented mechanistic modeling techniques for the scale-up and optimization of protein chromatography.