Bio

Peter Walters specializes in concept designs for gene therapies, autologous and allogeneic cell therapies, monoclonal antibodies and aseptic novel processes, in both stainless steel and single-use equipment. With hands-on experience in process development, he has a strong talent for understanding space use and equipment troubleshooting and has a particular interest in opportunities for creativity. Career Highlights: - Designed equipment and processes for manufacturing of bioprocess and pharmaceutical drug products. - Performed aseptic process scale-up to various pilot scales and product manufacturing for clinical studies (Phases I, II and III) and commercial manufacturing. - Designed, developed and validated processes for aseptic production systems. - Extensive experience with CGMP manufacturing: documentation (preparation of SOPs and batch records), commissioning and validation of processes, manufacture of clinical and commercial products. - Considerable troubleshooting experience, including all equipment, processing and product analysis related issues. - Facility CGMP design, GMP flows, classifications and pressurization design.