Emi Zychlinsky

Emi Zychlinsky has over 30 years of work experience in the medical device industry. Emi began their career in 1989 as the VP of Operations at Hitachi Chemical Diagnostics, where they were responsible for research and development, manufacturing, procurement, materials, quality and regulatory. Emi lead a team of scientists in the development and commercialization of several allergy diagnostic tests in multiplex formats, including instrumentation and software for process automation. Emi also managed the quality system and was responsible for US clearance, CE mark and regulatory approval in several countries including Japan.

In 2011, Emi moved to dia Dexus as the CTO, where they were responsible for product development and commercialization, quality, regulatory and manufacturing. During their time there, they obtained ISO13485 certification in 8 months, optimized and expanded the manufacturing capabilities for the PLAC Lp-PLA2 ELISA product by more than 6X with significant improvement in margins, developed the PLAC Test for Lp-PLA2 Activity, obtained CE mark for the introduction of the product in the European market, identified, negotiated and managed the cohort required for clinical validation testing (over 8,000 patients required for FDA submission), managed the 510(k) submission process with regulators which resulted in FDA clearance for the product, and secured and managed a multimillion dollar contract for testing over 61,000 subject samples for two large pharmaceutical clinical trials with complex coordination between multiple international and repository sites. Emi also participated with the executive team in the identification and expansion of a new pipeline, resulting in the licensing of 3 heart failure proprietary cardiac markers, and defined the regulatory and development strategy and moved the first one into development under design control.

In 2016, Emi moved to Fluidigm Corporation as the Sr. VP of Quality and Regulatory. In 2022, they moved to their current position as the Executive Vice President of Operations and EVP of Operations at Exai Bio.

Emi Zychlinsky received a Ph.D. in Medical Microbiology and Immunology from Stanford University between 1979 and 1984. Emi also received a Ph.D. in Medical Microbiology and Immunology from Stanford University between 1979 and 1983.