With over 20 years of experience, I am a seasoned expert in in In-Vitro Diagnostics (IVD) product development and launch. My expertise spans leadership, operational efficiency, and team building, allowing me to establish meaningful organizational goals that enhance the customer experience and foster a positive workplace environment. Throughout my career, I have successfully managed multifunctional teams leveraging my in-depth knowledge of Product Development, Regulatory Affairs, Quality Assurance, and compliance with standards including QSR, cGMP, ISO 13485, and IVDR. I possess extensive experience in immunoassay and molecular development. I take pride in mentoring scientists, nurturing their growth from early stages to confident, resourceful professionals. My exceptional ability to manage multiple functions in high-pressure environments ensures that I deliver outstanding results, even with demanding timelines. Supported by strong academic credentials and a record of impressive publications and presentations, I am eager to connect and collaborate with like-minded professionals in the industry.Areas of Expertise: Executive Leadership  In-Vitro Diagnostics  Immunoassay  Product Development and Launch  Mentoring and Teambuilding  Quality Assurance  Regulatory Submissions  Risk Management  Written and Presentation Skills  Efficient problem solving  Strong Interpersonal Skills Stability Programs Research and Development Life Sciences Protein Purification Molecular BiologyGMP GLP ISO 13485 IVDRQuality System QSRProtein ExpressionDesign ControlProject Management