Pleasanton, California, United States
Roche Sequencing Solutions harnesses over eight years of leadership in designing and delivering automated next-generation sequencing (NGS) solutions for IVD assays. Collaborated with multidisciplinary teams to drive system engineering initiatives, aligning with cross-functional groups like Regulatory, Operations, and Quality Management to ensure seamless product development and compliance. Focused on translating complex customer needs into actionable product requirements, enabling successful product launches. Motivated by a passion for biotechnology and life sciences, the team consistently delivers solutions that enhance laboratory efficiency and diagnostic capabilities.
In my role at Roche Sequencing Solutions, I spearheaded the development of a fully automated sample preparation solution for next-generation sequencing (NGS) systems. I successfully led a multidisciplinary team through complex interdependencies, ensuring the timely launch of the AVENIO Edge system. My responsibilities included extensive collaboration with various departments, enhancing operational efficiency and stakeholder engagement.
I successfully led the development of an automated sample preparation solution, driving innovation in next-generation sequencing. • Oversaw all system-level product development activities, ensuring alignment with project goals. • Collaborated with various teams to identify cutting-edge technologies, enhancing our competitive edge. • Played a key role in establishing a new Design Control Process, improving operational efficiency and product quality.
I successfully led the development of a pre-analytic system that transformed molecular diagnostics efficiency. • Oversaw a multidisciplinary team, ensuring alignment between engineering, regulatory, and quality management functions. • Drove the translation of customer requirements into clear product and software specifications, enhancing project clarity. • Cultivated strong relationships with third-party vendors, ensuring seamless integration of software, hardware, and consumables.
I successfully led the development of an automated nucleic acid purification and Real-Time PCR system, resulting in multiple regulatory approvals. • Defined testing strategies that improved product reliability and user satisfaction, contributing to market success. • Developed comprehensive training programs for customers and internal teams, enhancing operational efficiency and support capabilities. • Authored critical documentation that facilitated smooth system installations and qualifications, ensuring compliance and performance standards.
Supported Roche Molecular Diagnostics instrumentation for clinical diagnostics applications (COBAS AmpliPrep and COBAS TaqMan) and research applications (LightCyler and MagNA Pure family). - Help customers develop, optimize and troubleshoot real-time PCR applications. - Provide pre-sales support to account executives in the form of presentations and instrument demonstrations with customers.