Director, Assay Development
Current• Direct and guide a team of scientists including technical leads and managers working on multiple NPD and sustain projects.• As the technical lead, directed and managed the design and development of the Xpert Xpress MVP test on moderate complexity and CLIA-waived platforms from concept to product launch (US-IVD).• Experienced in all aspects of development of in vitro diagnostic assays, including: - Oligo design, screening and optimization; - Multiplex PCR optimization uisng DOE; - Sample preparation/nucleic acid isolation optimization; - Designing and performing analytical studies, and writing reports and IFUs/QRI to support 510(k) submissions; - Creating and validating test methods and SOPs for Manufacturing; - Working with external vendors to develop control materials for Clinical trials, Manufacturing and QC uses; - Problem solving and troubleshooting; - Developing alternate PCR assays to resolve discrepants in Clinical trials; - Supporting and working closely with cross-functional teams including Project Management, Product Transfer, Clinical Affairs, Regulatory Affairs, Medical/Scientific Affairs, Marketing, Quality System, Failure Investigation, System Integration, Software Engineering, Technical Support, Consumables Engineering, Supply Chain and Manufacturing
