Kevin Wiest

• Execute in-process and post thaw final drug product stability, comparability, and method qualification testing. • Develop SOPs while implementing new laboratory instruments. • Contribute to protocol and test method development/improvement • Actively contributing Safety Committee team member

• Optimized procedures for daily tournament set-up and clean-up while accommodating for changing priorities • Manage a team of 20+ volunteers to facilitate tournament operations with minimal supervision • Lead Tournament Set-Up and Take-Down each morning, delegating tasks to 20+ volunteers • Created a video that showcased the playing fields used. • Work in a small team to verify (2700+) player and coach credentials • Exercise creative problem-solving • Constructed stable relationships with vendors, teams, referees, and other tournament staff • Developed a user reference guide to streamline the team check-in process for both team and event administrators in lieu of mitigating hundreds of avoidable user reported issues via email.

Quality Control Experience: • Act as QC Lead for Client projects - Maintain and monitor inventory of individual client project materials - Generate CoT using MBR - Interact with clients regarding QC related issues - Propose solutions and improvements to existing problems/assays • Flow Cytometry (10-Color) - BD FACS Canto II - BD FACS Calibur - MACSQuant Analyzer 10 - Cell and bead-based compensation - Experiment and Analysis Template Development • Other Equipment Trained On: - Chemometec NC-200 - ViCell XR Cell Viability Analyzer - Beckman Coulter AC•T DIFF Hematology Analyzer - Mettler Toledo SevenCompact pH Meter 220 - Siemens RAPIDPoint 500 Blood Gas Analyzer - OsmoTECH® Single-Sample Micro-Osmometer - EVOS XL Core Imaging System • Writing & Executing - Standard Operating Procedures for equipment and processes - Work Instructions for cell-based assays • Independently initiate & prioritize projects • Responsible for delivering and documenting training for assigned procedures • Stability Testing • Hemocytometer Assays • Cell Culture Assays • Created and tracked KPIs • Analytical equipment troubleshooting and maintenance Compliance Investigator Experience: • Conduct and assist in OOS test result investigations • Prepare Major Deviation Reports Quality Assurance Experience: • Document Control - Change Controls (processes/ new equipment) - Triennial Document Review Validation/IT Experience: • Assist in the execution of software validation protocols