EDUCATION: University of Puerto Rico (Mayagüez Campus -CAAM) BS, Biology (75 credits in Biology, 27 in Microbiology); MS, Microbiology - Phytopathology (56 credits, 32 in Microbiology)
BACKGROUND SUMMARY: Managerial, supervisory, qualification-validation, auditing, equipment design/selection and process development experience at corporate level, QC and Manufacturing. Work has been done for biotechnology (mammalian cells culture; bulk/ finished product), sterile products (LVP, SVP, suspensions, solutions, ophthalmic, otics, ointments, lyo, pre-filled syringes, bags, etc.), bulk pharmaceutical chemicals, fermentation (bio-transformation & fermentation) and non-sterile pharmaceuticals (solids, liquids & semi-solids). Experience on equipment/ facility qualification processes (URS to IOQ-PQ), facilities layout evaluations & cleaning validation. Knowledge of isolation/ containment technology - VHP cycles development; autoclaves cycles development (saturated steam, air-steam mixture & superheated water). Good understanding of utilities and facilities. Experience on gowning/ aseptic technique (many trainings developed).
Expert in pharmaceutical microbiology has broad practice in process troubleshooting. Combined academic studies, applied concepts, continued education and extensive pharmaceutical experience allow to be a resource. Fungi (molds & yeast) and bacterial contamination issues have been addressed many times with excellent results. Consultant on disinfection/ disinfectants validation. Conferences on fungi taxonomy, environmental monitoring, BET, water systems, bacterial taxonomy, etc. This include the University of PR, Mayagüez, Campus.
Experience as microbiology profesor at Sagrado Corazón University.