Darin Dudley Email & Phone Number

Raleigh, Nc, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

-Execution of large scale production processes to meet manufacturing and business requirements.-Involved in process scale-up, process optimization and process validation activities.-Fully trained on Fermentation, Extraction, Centrifugation and Depth Filtration processes in the production of seasonal influenza vaccination drug substance.-Lead in Fermentation process; in charge of production scheduling, training and operation of 125L bioreactors.-Performs execution of shake flasks inoculation in the biosafety cabinet.-Process owner in Centrifugation; in charge of training and coordinating maintenance and calibration activities.Performs aseptic sampling: TOC, conductivity, bioburden and endotoxin, to verify cleanliness of process equipment.-Developed cleaning protocols for process equipment alongside validation.-Lead on ordering process materials in ERP to ensure process suites are stocked and ready for processing activities.-Authoring of SOPs and batch records.

-Serves as Safety Team Lead presenting monthly safety presentations.-Completed the Train-the-Trainer course and currently train personnel to meet company goals.-Receive and distribute materials utilizing SAP system.-Perform aseptic manipulations and aseptic gowning techniques.-Perform environmental monitoring to ensure environmental sterility.-Operate robotic cell culture system during cell plant, refeed and inoculate processes.-Perform macroscopic/microscopic observations.-Adhere to cGMP practices while working in a team environment to achieve departmental goals.-Identify and address compliance, environmental, safety and process deviations.-Maintain, clean and prepare equipment used in virus production.-Provide timely delivery of samples and materials to appropriate laboratories.

-Provide excellent customer service and clerical support-Answer patron questions -Conducted tours of Hunt Library-Checked out/received materials -Use large format printers to print posters for patrons-Assist with other projects as needed

-Act as a liaison between University Recreation and event clients-Supervised all departmental functions and employees on staff-Enforce facility guidelines while controlling access to the gym-Greet patrons and provide information regarding University Recreation -First Aid and Adult CPR/AED certified