Over 20 years of cGMP experience in microbiology and biopharmaceutical industry. Expertise in microbiological industry practices and regulatory guidelines.Joined Morphotek in 2010 where I was responsible for the start-up of new microbiology laboratories and all microbiology related programs needed to support a new construction Pilot Plant facility producing multi-product Phase I and II Clinical monoclonal antibody materials for global distribution. Worked with cross functional teams to finalize construction, bring facility up, validate the facility including critical utilities such as WFI, CS, RODI, compressed air, N2, O2, CO2, and an ISO 14644 classified manufacturing environment. Created and implemented quality and laboratory systems to support manufacturing of global GMP products. Highlights include creating, implementing and training staff on programs such as gowning, sanitization, segregation, biocontamination control program, Quality Control sampling, setting appropriate alert and action levels, and tracking and trending of all QC data. The project is a success and producing global compliant GMP material within 4 years time.Extensive experience with bioburden, endotoxin, microbial identifications, mycoplasma and viral safety testing of monoclonal antibodies, TOC, creation of raw material testing program including creation of specifications, RM testing and release, biological indicators, disinfectant efficacy, writing of policies, procedures, work instructions, and technical reports. Created and implemented internal auditing program to ensure continued compliance and harmonization.Have developed a cohesive team of microbiologists with varying skill levels to support all microbiological tesing.