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Director of ATMPs
San Diego, CA
Peter Walters is a process engineer with 15 years of experience specializing in pharmaceutical process and facility design. He has designed equipment and processes for the multi-step manufacturing of pharmaceutical drug products, performed scale up of aseptic bulk process to various capacities and product manufacturing for clinical studies in phases I, II and III. His experience includes the design, development and validation of clean-in-place and sanitize-in-place processes for aseptic bulk production systems. Peter has extensive experience with CGMP manufacturing, including generation of procedures and batch records, validation of systems and processes and the manufacture of clinical and commercial products.
His expertise includes experimental design, process characterization, equipment and process troubleshooting and manufacturing for clinical phase I through commercial production. He is well versed in production performance and process and product analysis. He has designed process facilities for monoclonal antibodies, gene therapies, autologous and allogeneic cell therapies and aseptic novel processes, in both stainless steel and single-use equipment. He has helped author a New Drug Application and has participated in Food and Drug Administration facility inspections. He is a co-inventor for a patented novel product formulation process. Peter was recognized by Consulting-Specifying Engineer with the 40 Under 40 award in 2018.
Throughout his career, Peter has taken a particular interest in opportunities for creativity. With his commissioning and pilot-scale experience, he has a strong talent for understanding equipment use and troubleshooting.
Peter graduated from the University of California, Davis with a degree in chemical/biochemical engineering. He is a Southern California native and enjoys playing soccer and spending time with his family in San Diego.