Process Development Scientist
CurrentLead Validation and Verification Scientist for studies required by FDA to obtain PMA and CLIA waiver clearance for Determine HIV Ag/Ab Combo.Worked on process development teams for rapid tests HIV DoubleCheck, HIV DoubleCheckGold, Clearview Chlamydia, ImmunoComb and Determine HIV Ag/Ab ComboLed international manufacturing technology transfers for 4 Veterinary Lateral Flow tests under USDA requirements ( From Agen, Australia to Orgenics), Clearview Chlamydia (From Unipath, UK to Orgenics) and Determine HIV Ag/Ab Combo (From Orgenics to Alere, USA)Involved in Product and manufacturing troubleshooting as well as product improvements for all Orgenics manufactured products.