Toronto, Ontario, Canada
At Traferox Technologies, my focus is on leading projects that support Ex Vivo Lung Perfusion systems, characterized by meticulous regulatory adherence and robust process validation. With a PMP certification and a strong background in biology, I apply a methodical and tactical approach to managing operations and ensuring compliance with stringent FDA/EU and Health Canada regulations. Our team's efforts concentrate on the orchestration of complex projects with budgets surpassing two million dollars, which demands exceptional coordination and risk management. Through collaboration with cross-functional teams and external Subject Matter Experts, we have successfully met project milestones, demonstrating my commitment to excellence and innovation in the medical device and pharmaceutical fields.
• Leading process development and validation activities for medical devices and pharmaceuticals which support Ex Vivo Lung Perfusion. • Orchestrating multidisciplinary projects with +2 million budgets. • Ensuring strict regulatory compliance with FDA/EU and Health Canada regulations. • Knowledge of systems development in alignment with ISO 13485. • Spearheading risk management initiatives and collaborated with cross-functional teams and external SMEs for project success.
• Led research projects on grapevine viruses, securing funding and presenting findings to industry stakeholders. • Managed cross-functional teams, oversaw laboratory analyses, and coordinated project finances for successful project execution.
• Managed harvest team, ensuring quality standards and regulations compliance. • Developed SOPs, trained new team members, and collaborated with executives for strategy. • Reported inventory to provincial and federal bodies.
During my time at Domaine Leon Barral in Faugères, France, I had the opportunity to work closely with renowned winemaker Didier Barral. I gained tangible insights into 'low-intervention' oenology and viticulture, focusing on detailed vineyard observation and traditional winemaking techniques.
• Managed laboratory operations including equipment calibration and Vintner's Quality Alliance (VQA) submissions. • Oversaw product packaging logistics from blending trials to quality assurance, ensuring compliance with regulations. • Trained and supervised temporary vintage staff, optimizing efficiency and productivity. • Maintained accurate bottled and bulk wine inventory reports for regulatory bodies.