Veronica D Hannah Email and Phone Number

o Execute microbiological research and development requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by senior management.o Provide risk-based approach to define and assess microbial controls for existing and new installations. o Develop preliminary schedules along with material/personnel/equipment requirements to allow accurate contract pricing and appropriate performance guarantees. o Design and facilitate installation, maintenance, and troubleshooting of the Novatek LIMs and Biolog system to meet the organizational needs for Environmental Monitoring: partner with technical staff to expedite the transition. Draft and execute validation and implementation plan. o In cooperation with customer representatives, identify process improvements in all laboratory areas. o Develop and Direct the Aseptic Training Program for Manufacturing.o Provide technical expertise, mentorship and oversight of the Microbiology and Environmental Monitoring Program; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.o Responsible for statistical trending of Environmental Monitoring.o Manage the budget for the Microbiology Laboratory.o Develop and author auditable Microbiological Standard Operating Procedures (SOP’s) and Test Methods.

o Coordinated and managed the daily activities of the Microbiology laboratory.o In cooperation with customer representatives, identify process improvements in all laboratory areas. o Developed and Direct the Aseptic Training Program for Manufacturing. o Provide technical expertise, mentorship and oversight of the Microbiology and Environmental. Monitoring Program; ensure team meets expectations and meets objectives; guide the professional. growth of team members by providing personal guidance and training relative to responsibilities. o Review product/process development and manufacturing operations for adaptability with existing facility configuration. o Responsible for statistical trending of Environmental Monitoring and budget management activities.o Develop and author auditable Microbiological Standard Operating Procedures (SOP’s) and Test Methods.o Performed Sweeps for GLP in the Microbiology Lab.o Trend and Troubleshoot manufacturing to locate sources of contamination.o Coordinated and administered annual reviews for each analyst

o Spearheaded the Start-up of the KBI Microbiology Lab, Cell Culture Environmental Monitoring o Created Standard Operating Procedures for Microbiology Laboratory and General Test Methods for Microbiology Manufacturing Testing Operations. o Performed Audits for GLP in the Microbiology Lab and water testing for Cell Culture and Microbial Manufacturing.o Trended and Investigated Environmental Monitoring within manufacturing to locate sources of contamination.o Initiated, Developed and Directed the Aseptic Training Program for Manufacturingo Created, Executed and Administered Gas Testing Program for Laboratory operations at KBI Biopharmao Performed Technical review on Microbiology and Environmental Monitoring Datao Performed Non-Host, Gel Clot Bioburden, Kinetic and PTS Testing o Reviewed/Trended Environmental Monitoring, Water Testing, Gas Testing data and implemented corrective actionso Reviewed and approved laboratory notebooks, logbooks and data for GLP compliance o Prepared Reports for investigations and provided the Technical Assessment for Laboratory Exceptions and Deviationso Created Safety Procedures for the Microbiology/ES Laboratory Departmento Initiated and Implemented the Gowning Training process/procedure for all manufacturing personnelo Responsible for ensuring that all instruments/equipment are calibrated and validated

Quality Control Microbiology Testing/Environmental Monitoring Supervisor

Quality Assurance Laboratory Coordinator