OKLAHOMA CITY, Jan. 15, 2018 (GLOBE NEWSWIRE) — Cytovance® Biologics, Inc., a leading full-service biopharmaceutical contract manufacturer of mammalian and microbial biologics, announces and welcomes Edwin Miranda as Vice President of Quality. Edwin Miranda will be leading the full breadth of Cytovance’s Quality function.
“With over 33 years’ experience in the biopharmaceutical contract manufacturing industry, Edwin brings a depth of experience in quality assurance, encompassing solid & liquid oral dose, biologics and cosmetics,” said Dr. Jesse McCool, Sr. Vice President of Research & Development. “We are very fortunate to have such a well-seasoned and experienced executive join our team. Edwin’s knowledge and leadership skills will be tremendous assets to the Company.”
Prior to Cytovance, Edwin oversaw the Quality Assurance team in a successful FDA approval and launch of the New Drug Application (NDA) for Keppra®. He has served as Director of Quality or Vice President of Quality Assurance URL Mutual Pharmaceuticals, Inc., Legacy Pharmaceutical Packaging, and Piramal Critical Care, Inc. In these roles, he managed the quality systems, oversaw regulatory compliance functions, and developed a successful remediation plan to correct 483 observations, resulting in receipt of an Establishment Inspection Report (EIR) in good standing. Edwin, an army veteran, holds a B.S. in Biology & Chemistry from Angelo State University in San Angelo, TX.
“Edwin, comes to Cytovance in impeccable timing for Cytovance’s first PAI scheduled for February 2018,” commented Mike O’ Mara Sr. Vice President of Manufacturing Operations.” With a number of our clients getting ready to file BLA’s in 2018, Edwin’s expertise with FDA inspections will make him an invaluable addition to the Cytovance team.”