Associate Principal Scientist
Monmouth Junction, New Jersey, US
- 1. Product Development & Regulatory Compliance. Oversaw the lifecycle of the iMOST COVID-19 Antibody testing system (instrument and consumables), from conceptualization to EUA filing.
- Defined product requirements, specifications, and project proposals.
- Collaborated and coordinated cross-functionally team to ensure milestones are met on schedule.
- Managed documentations, including test reports, SOPs, specifications, 510(k), IFUs, and patents.2. Research and Development Lead of multiple products on the pipeline.
- Principal scientist for diagnostic immunoassay development.
- Led on assay/reaction optimization in terms of performance and product shelf life