Lead the activities to develop microbiological methods to assess the purity, potency, other key attributes, and stability of drug substances and finished products performing testing including sterility, endotoxin, bioburden/microbial limits, ELISA, sub visible particulate, and microbial identifications. Key Responsibilities: Performs and maintains accurate, detailed records for method development/optimization, method transfer/suitability/validation, and for routine analysis of finished pharmaceutical dosages and/or raw materials following approved analytical methodology and specifications to pharmaceutical cGMP requirements.