Tom Krieger Email and Phone Number

• Optimize process description for clinical and commercial manufacturing• Create and align downstream batch records according to the process description• Ensure manufacturing personnel adhere to cGMP regulations• Evaluate, author, and revise cross departmental Standard Operating Procedures, Work Instructions, and Master Batch Records for upstream and downstream manufacturing • Write and review methods on Unicorn software for Cytiva AKTA Ready for Affinity Chromatography and Anion Exchange Chromatography• Function as a Subject Matter Expert to train upstream and downstream associates on process theory and operations with an emphasis on Depth Filtration, Affinity Chromatography, Anion Exchange Chromatography, and Tangential Flow Filtration• Lead a team of 7 team members during downstream unit operations• Train upstream and downstream associates on process specific equipment • Execute full small-scale process runs with the process development department• Manage coordination with Warehouse for processing kits while maintaining general stock inventory levels • Support and execute validation of upstream and downstream equipment• Review batch records and equipment logbooks for necessary revisions• Provide guidance and audit cleanroom cleaning specialists to ensure sterility• Assist quality control department with routine environmental monitoring including sampling and plate reads• Initiate, investigate and write up deviations, CAPA’s, and Change Controls

• Optimized process description for clinical and commercial manufacturing• Created and aligned downstream batch records according to the process description• Ensure manufacturing personnel adhere to cGMP regulations• Authored Standard Operating Procedures for relevant upstream and downstream equipment• Evaluated, authored, and revised cross departmental Standard Operating Procedures for upstream manufacturing • Create and review methods on Unicorn software for Cytiva AKTA Ready for Affinity Chromatography and Anion Exchange Chromatography• Function as a Subject Matter Expert to train upstream and downstream associates on process theory and operations with an emphasis on Depth Filtration, Affinity Chromatography, Anion Exchange Chromatography, and Tangential Flow Filtration• Train upstream and downstream associates on process specific equipment • Executed full small-scale process runs with the process development department• Manage coordination with Warehouse for processing kits while maintaining general stock inventory levels • Support and execute validation of upstream and downstream equipment• Review batch records and equipment logbooks for necessary revisions• Provide guidance and audit cleanroom cleaning specialists to ensure sterility• Assist quality control department with routine environmental monitoring including sampling and plate reads• Initiate, investigate and write up deviations, CAPA’s, and Change Controls