• Generate and maintain manufacturing records to comply with ISO 13485
• Assist in development and scale-up of reagent manufacturing protocols
• Assist in transition of pilot lots from Research and Development to full production
• Maintain inventory in Enterprise Resource Planning (ERP) program, Expandable
• Order and receive manufacturing inventory according to company specifications
• Communicate between departments to provide raw materials, reagents, and final product for internal use without compromising sellable
inventory or planned manufacture
• Maintain lab notebook for the manufacture of custom, made-to-order products
• Train and orient new hires
• Formulate biochemical reagents in accordance with ISO 13485 requirements and Standard Operating Procedures.