Chris Ernst

Chris has more than 27 years in industry, with a background that includes environmental, cGMP, clinical, and non clinical GLP laboratory operations, as well as phase I-IV clinical research and oversight including small molecule, proteins, biologics and monoclonal antibodies, and combination products and medical devices. Since 2013, he has led development of the Quality Management Systems in support of the preclinical and clinical development as well as manufacturing of drug substance and drug products in the development of AKB-9778 and AKB- 4924 (now GB004) while at Akebia and Aerpio, and currently leads the areas of Chemistry, Manufacturing, and Controls (CMC) and Quality Assurance for Aerpio. Formerly with Akebia Therapeutics, Chris supported development of the quality management system in a similar way, supporting the preclinical and clinical development as well as manufacturing of AKB-6548 and AKB-6899. His manufacturing experience covers all aspects global current Good Manufacturing Practice regulations and includes solid oral dose and capsules, topical creams and ointments, liquid fill, personal care products, and sterile parenteral formulations for intravenous, subcutaneous, and topical ocular routes of administration. Prior to joining Aerpio and Akebia, Chris led the development of the global quality management system of Medpace, a mid-sized Clinical Research Organization based in Cincinnati, OH, developing quality systems in support of Good Clinical Practice, Good Laboratory Practice, central laboratory (CAP/CLIA), medical device, and imaging services. Chris obtained his B.S. Degree in Biology with a minor in Chemistry from Northern Kentucky University.