Senior R&D Scientist
Medford, New York, United States
• Key personnel in build out of novel DPP® Syphilis Treponemal & Non-Treponemal multiplex assay with parallel IgG and IgM detection; funded by CDC for a cumulative 7 figure contract.• Development of the DPP® SARS-Cov-2 Antigen Assay system and the DPP® Respiratory Antigen Panel system (Influenza A, Influenza B, SARS-CoV-2 multiplex) from feasibility to production transfer. Project received 8 figure grant from BARDA.• Research and draft of experiment for assay development: antibody production, conjugation (carboxylation, biotinylation, etc), ELISA/CLIA development, liposome preparation etc.• Preparation of Batch Records, Monographs, and SOPs. Route design transfer from R&D to production/QC.• Thorough design and execution of non-clinical protocols and Long-term/Accelerated Stability studies. Completion of respective reports and other regulatory documents, which lead to successful submissions to Regulatory agencies (FDA, CE, ANVISA, Health Canada).• Effective prioritization, training, and delegation of project specific tasks to adhere to Gantt Charts.• Aided in production of SARS-CoV-2 microfluidic devices in strategic partnership with UK based Lumira Dx.• Serve as Safety officer for R&D department and engage in liaison with EHS department. Responsible for implementation of CAPAs within the lab areas.