Scientific lead in a multidisciplinary team in the design, development, and optimization of innovative medical devices within the complex biologics sector. Responsible for overseeing product development lifecycle, from conceptualization through to regulatory submission and commercialization. Collaborate closely with cross-functional teams, including R&D, regulatory affairs, and clinical specialists, to ensure the integration of cutting-edge technology. Managed project timelines, budgets, and risk assessments while ensuring compliance with industry standards and regulatory requirements. Utilized deep expertise in cell and molecular biology to drive the successful translation of novel therapies into market-ready products, improving patient outcomes in challenging therapeutic areas.Developed novel web applications for Quality Metrics analysis for a biotechnology company expanding into the manufacture of medical devices. Characterized and remediated corrective and preventive action processes to meet medical device reporting regulations. Developed and managed a Complaint Process remediation project for issues related to diagnostic devices.

Developed novel protein silencing technology through rational design of ubiquitin ligases. Extensive experience with protein biology in in vitro, bacterial, and mammalian systems. Knowledge of glycobiology, immunology, and cancer biology through interdisciplinary biomolecular engineering applications.