Ms. Chesterfield Yonker has over twenty years experience in the Pharmaceutical, Biotechnology and Medical Device industries. She is currently Associate Director of Commercial Manufacturing at Heron Therapeutics, Inc. Prior to this held positions at Novartis and J&J, as well as several consulting engineering firms. Her experience includes project management, quality, operations, and validation. She has expertise in aseptic processing, biological containment, oral solid dose, drug/device combination products, and in vitro diagnostics. Recent projects have focused on launching commercial products, oversight for the manufacturing of clinical trials materials and implementation of Process Validation Lifecycle for legacy products. She has been actively involved with ISPE for over 10 years. Her ISPE activities have included presentations at multiple chapter events, training sessions and Annual meetings and CoP Steering Committies..