Process Engineer Ii
Current• Designed and led the execution of manufacturing tolerance studies to set QC physical property specifications.• Designed/authored CLSI-compliant stability study designs/protocols for critical assay reagents.• Created analytical QC instrument calibration and measurement methods tailored to specific reagents.• Continued supporting on-time manufacturing and delivery of monthly R&D reagent requests.• Assisted with executing bead mix QC processes on common analytical QC equipment.• Helped draft several Reagent Completion Forms, Manufacturing Standard Operating Procedures (SOPs)/Manufacturing Batch Records (MBRs), and other critical documentation for several reagents.