With over 33 years of experience in the biopharmaceutical contract manufacturing industry, Edwin has built a successful career around quality assurance which encompasses solid and liquid oral biologics, dose as well as cosmetics. Edwin has demonstrated an outstanding leadership style in his career.
Recently, his vast knowledge and great leadership skills landed him a new job as Vice President of Quality at Cytovance Biologics, a biopharmaceutical company. His transition to the company was smooth and heart-warming as executives in the company took it to the stage to welcome him to the company. He is now in charge of Cytovance’s Quality function. Dr. Jesse McCool, Senior Vice President of Research and Development, regarded Edwin Miranda as a well-seasoned as well as experienced executive.
Before joining Cytovance early this year, Edwin Miranda led the Quality Assurance team which was mandated with the role of securing FDA approval for New Drug Application (NDA) for Keppra. Edwin served at Quality Assurance URL Mutual Pharmaceuticals, Inc., as Vice President or Director of Quality. He worked at Legacy Pharmaceuticals Inc., Piramal Critical Care, and Legacy Pharmaceutical Packaging. Edwin has been in charge of regulatory compliance functions, quality systems and at one point, he helped in the development of a remediation plan that served to correct 483 observations. The development of the remediation plan resulted into receipt of Establishment Inspection Report.
Edwin served in the army before changing careers. He graduated with a B.S. in Biology and Chemistry from Angelo State University in TX. Edwin Miranda joined Cytovance at a time when it was preparing for its first PAI which was scheduled for February this year. He has been an invaluable asset to the company even as the company’s clients prepared to file BLA’s. His expertise with FDA inspections places him in a position to get the company more FDA approvals. Cytovance specializes on the production of therapeutic proteins as well as antibodies from mammalian cell culture as well as microbial fermentation.
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