Director of Quality
Miguel Castellanos is a highly accomplished GxP professional with 25 plus years of experience. From hands-on bench / floor to Directorship. From small start-up to multi-national corporations. A broad & strong combination of experiences (analytical R&D, QA/QC, APIs, FD, Cosmetics, OTC, Consumer Products, Contract Organizations). Developed, implemented, and managed the cGMP program, from Pre-Clinical to Commercial, for a startup CRO/CMO company (Girindus America), and successfully passed a 3-day, unannounced, quality FDA audit, with no findings or objectionable items. Experienced with other FDA audits with different companies in different quality roles, with the record of never receiving a citation from the FDA. Holds a MSc in Analytical Chemistry from Western Carolina University, and a BS in Chemistry from Universidad Autonoma de Santo Domingo (Dominican Republic). Fluent in Spanish.