Michael Aungst Email and Phone Number

Receive, identify, and inventory incoming parts in Grand PM maintenance shop database. Work with maintenance personnel to identify and secure parts necessary to repair broken or malfunctioning equipment. Train new personnel, stressing the importance of cGMP’s and adherence to all SOP’s, while helping to maintain an audit ready status for the facility.

- Prepare equipment and batch records for production in each step of the manufacturing process.- SME (Subject Matter Expert) in MES (Manufacturing Execution System), a new electronic batch record being utilized site wide.- Yellow Belt Certified for Process Improvement- Served as Plant Safety Liaison performing monthly safety audits, uploading results to SharePoint site, and scheduling corrective actions through SAP.- Routinely performed Column Chromatography, Purification, Concentration, Ultrafiltration/ Diafiltration, Planova Filtration, and Tangential Flow Filtration.- Perform CIP and SIP of vessels, chromatography skids, and transfer lines.

- Managerial duties included daily management of and operation of a nuclear manufacturing facility and the site’s personnel- Demonstrated management skills by operating within manufacturing budget while maintaining and controlling supplies, inventory, shipping, and receiving.- Responsible for oversight of all employees’ training, supervision, performance appraisals, and evaluations, as well as professional development.- Responsible for compliance with all applicable FDA, DOT, and NRC regulations.- Responsible for startup and day to day operation of cyclotron and coincidence chemical synthesis boxes.- Coordinate product release times with the pharmacy to ensure timely dose dispensing and dispatching of drivers.- Perform weekly inventory in order to maintain appropriate levels of all materials and ensure that the materials are approved for use and within expiration dates.- Perform all daily Radiation Safety Checks to ensure compliance with all regulations.

- Prioritized, scheduled, and tracked daily team activities based on scheduling demands as well as resource availability.- Collaborated with supervision to determine best course of action and deployment of personnel to meet production goals.- Increased operational efficiency through revision of Standard Operating Procedures (SOP's) and Master Batch Records (MBR's).- Provided training to all associates and monitored training levels to ensure appropriate coverage in all production areas.

- Member of a supervisory team that managed the work and schedules of a 12-Technician Laboratory in the production of FluShield, an influenza vaccine. - Ensured 100% use of aseptic techniques, current Good Manufacturing Practices, (cGMP's),and SOP's to produce highest quality products. - Collaborated with team members to review all MBR's, logbooks, printouts, and temperature/humidity logs. - Reduced production downtime and product waste through proactive communication with several departments. - Performed chromatogaphy of Influenza viral fluids using Amicon Moduline Liquid Chromatography Columns. - Cleaned and sterilized stainless vessels and process piping using an Allen Bradley CIP skid and temperature recorder.