The purpose of this position is to assist in establishing and managing a microbiology program that oversees aseptic fill/finish activities, environmental monitoring, gowning qualification, and the establishment of compendial microbiology assays that include endotoxin, bioburden, and sterility. Serve as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits.