Who We Are

Seasoned professional available to share extensive knowledge of IVD product development, coaching/mentoring, and shaping R&D and business area operational models



AREAS OF EXPERTISE AND CAREER HIGHLIGHTS

Over 30 years of IVD industry and academic experience from research scientist to senior director level positions
Deep understanding of medical diagnostics industry, product development and design control in regulated environment. Extensive experience working with global regulators (FDA, BSI, NMPA, MHLW), supranational bodies (WHO) and NGOs (Global Fund, Gates Foundation). 
Directly involved or oversaw the development and successful launch of more than 30 IVD molecular diagnostics products and 3 diagnostics platforms of various throughput. Focus areas include microbiology, virology, sexual health, and blood safety.  
Served as subject matter expert in several due diligence (M&A) campaigns, numerous supplier audits/qualification. 
Leadership and mentoring abilities proven in numerous interdisciplinary and cross-functional projects and successfully established working teams across cultural and language borders. Proven track record of leading highly scalable, agile teams operating across international and cultural boundaries
Strong scientific and technical background in physical chemistry and biochemistry combined with solid experience-based understanding of hardware/software design and engineering.
 

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