Biomanufacturing Specialist
• Developed automation workflows to generate custom prefilled PDFs via Smartsheet, facilitating new hire charge code requests while managing current project database and tracking response times.• Developed centralized MDI board for all 3 MFG departments. Leveraged generated data for actionable insights on items such as safety events, quality events, QMS records by tracking variances using the pareto principle. • Developed one-stop-shop QA Helpdesk ticketing system to strengthen MFG/QA communications, track metrics and save $6,277.40 annually on software licenses. • Act as a subject matter expert in Upstream/Downstream related activities potentially including adherent and suspension cell culture at small and large scale, cell transfection, media and buffer preparation, bioreactor and fermenter-based production, depth filtration, chromatography purification, centrifugation and ultracentrifugation, ultrafiltration/diafiltration, and viral clearance.• Work with Tech Transfer and Technical Operations groups for efficient process design and transfer into the cGMP compliant process suites.• Draft Standard Operation Procedures, Work Instructions, Change Controls, and Deviations, and other controlled documentation.• Interface with Validation and Calibration engineering teams for startup, testing, and operation of Manufacturing equipment• Properly disinfect and stage materials and equipment into production rooms before the production campaigns.• Order equipment and perform installation, qualification, and routine maintenance. Interfaces, schedules, and performs on-site monitoring of outside services of all Manufacturing equipment.• Draft and collaborate on Production batch records and review executed records.• Write raw material specifications. research, source, and order material and lab wares.• Lead activities to support production campaign such as preparation of tubing assemblies, autoclaving, material request, and material transfer into production rooms.
