Ferda Yantiri-Wernimont, Ph.D. Email & Phone Number

Oceanside, California, United States

Founded and managed my own start-up company with a core business in developing highly sensitive and specific rapid diagnostic assays. Successfully developed several rapid diagnostic assays for infectious disease targets such as COVID-19 antibody and antigen assays, biomarker assays for organ transplant and immunological response to COVID-19.Developed business strategies and managed all operations and business activities including payroll, contracts, tax, permits and customer relationships… Show more Founded and managed my own start-up company with a core business in developing highly sensitive and specific rapid diagnostic assays. Successfully developed several rapid diagnostic assays for infectious disease targets such as COVID-19 antibody and antigen assays, biomarker assays for organ transplant and immunological response to COVID-19.Developed business strategies and managed all operations and business activities including payroll, contracts, tax, permits and customer relationships. Managed the entire research and development activities including initial research plan, product design, reagents and material selection, vendor relationship, preparation of RMS, SOPs, BOM, DFMEA, PFMEA, design control documents, verification and validation plans/protocols. Performed verification and validation studies and prepared reports. Worked with Regulatory bodies to ensure product meets regulatory requirements. Drafted clinical trial protocols and user studies for clients. Directed small scale manufacturing and collaborated with manufacturing companies for high throughput production needs. Show less

Carlsbad, Ca

Managed R&D group through strategic planning and project development activities. Led, managed and coordinated activities with project teams to ensure successful development and transfer of products including: recruiting and retaining talent; establishing and maintaining clear roles and responsibilities; developing expertise to support and collaborate with global Trinity Biotech sites as appropriate, and ensuring adequate resource utilization.Developed POC lateral flow assays for several… Show more Managed R&D group through strategic planning and project development activities. Led, managed and coordinated activities with project teams to ensure successful development and transfer of products including: recruiting and retaining talent; establishing and maintaining clear roles and responsibilities; developing expertise to support and collaborate with global Trinity Biotech sites as appropriate, and ensuring adequate resource utilization.Developed POC lateral flow assays for several infectious diseases including HIV, Malaria and Syphilis.Developed a multiplexed Lyme Disease next generation assay. Facilitated efficient and effective transition of products from R&D to Manufacturing Operations at multiple Trinity sites, which included coordination of all activities from feasibility to transfer. Worked collaboratively with Quality Assurance and Regulatory to ensure products met regulatory requirements. Provided expertise for FDA/ISO Quality System requirements, Design Control and Risk Management, Design Verification, Validation and product submission/registration knowledge. Managed clinical evaluation including site selection, preparing protocols and working closely with FDA for 510K and PMA submissions. Show less

Supervised an assay development team that developed novel fluorescent immunoassays, including: assay conception through feasibility, optimization, validation, transfer from R&D into manufacturing and delivery to the market with 510K clearance. Managed the biological reagent group; this team was responsible for assay concept, the antigen selection, the antigen design, monoclonal antibody development and antibody productions.Supervised the analytical methods group; this group was… Show more Supervised an assay development team that developed novel fluorescent immunoassays, including: assay conception through feasibility, optimization, validation, transfer from R&D into manufacturing and delivery to the market with 510K clearance. Managed the biological reagent group; this team was responsible for assay concept, the antigen selection, the antigen design, monoclonal antibody development and antibody productions.Supervised the analytical methods group; this group was responsible for the development of analytical methods that are used while qualifying immunoassay components. Show less

Developed projects and made decisions pertaining to the design, selection and establishment of critical immunoassay components, including monoclonal antibodies and antigens

Conducted new product development via research phase and assay design, antigen design, antibody screening, and sandwich antibody pair detection.Developed and validated analytical methods for that were subsequently utilized to ensure that the for market immunoassays met quality standards; additionally composed manufacturing instructions and test documents for the said methods.

Therapeutic Antibody Development by using phase display technology

Developed studies that have significant potential in the development of a novel therapy for Parkinson's disease. Adviser: Dr. Julie Andersen

Purification and initial characterization of tumor specific NADH oxidase. Adviser: Dr. James Morre

Run Clinical Lab. Mainly hematology and blood banking

Phd, Biochemistry And Molecular Biology

Bs, Biology