Chris Ernst
Chris has more than 30 years in industry, with a background that includes laboratory operations management of environmental, cGMP, clinical, and non-clinical GLP services, as well as phase I-IV clinical research and oversight including small molecules, proteins, biologics and monoclonal antibodies, gene therapy AAV’s, combination products, and medical devices. Since 2013, he has worked in the biotechnology space leading development of Quality Management Systems in support of preclinical and clinical development as well as leading the development and cGMP manufacturing of drug substance and drug products in the development of clinical and commercial assets. Currently he leads the area of Chemistry, Manufacturing, and Controls (CMC) for Opus Genetics to advance the IRD and small molecule assets in the pipeline through early stage clinical development through commercial manufacturing. His manufacturing experience covers all aspects of global current Good Manufacturing Practice (cGMP) regulations and includes solid oral dose and capsules, topical creams and ointments, liquid fill, personal care products, nanoparticles, and sterile parenteral formulations for intravenous, subcutaneous, intravitreal, sub-retinal, and topical ocular routes of administration. Chris obtained his B.S. Degree in Biology with a minor in Chemistry from Northern Kentucky University.
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11-Feb-2026Theatre 2Building scalable viral vector manufacturing models