Bio

Proven in vitro diagnostic executive with 18 years of experience in all segments of design controlled development of immunoassays, molecular assays, multiplex assays, point of care (PoC), integrated platforms, and instrumentation. Managed or directed major programs leading to development of +30 multiplexed assays with integration or co-development on 7 different instrument platforms. • System-level diagnostic development leader • Design control ISO 13485, 21 CFR 820.30 • Regulated products (FDA, CE, CLIA, USDA) and RUO • CLIA high, moderate, waived tests, PoC, Home use • Clinical affairs, GCP, Human Subjects Research • Design transfer to manufacturing • Design verification and validation • Design history file • CAP-Accredited, CLIA-Certified, NYSDOH approved lab leadership experience, 42 CFR 493 • ISO15189 trained