CEO and co-founder of Blue Ocean Biomedical, Mike has more than 30 years of executive experience in the biotechnology industry. With a background as a Medical Technologist, Mike then moved into sales and also earned an MBA from the University of Miami. As a corporate office executive with Coulter Corporation, Mike developed rich experience in business development, in structuring strategic partnerships with other corporations, and in managing worldwide sales, service and marketing. One of his roles was to develop and manage Coulter's relationship with Immunotech of Marseille, France, a leader in monoclonal antibody develpment and assay kits for the determination of hormones, tumor markers, cytokines, etc.
In 2001, Mike co-founded and became CEO of NPE Systems, to develop innovative concepts for flow cytometry systems. Then, in 2009, with plans in place to take new immune monitoring system concepts to market, Mike became a co-founder and CEO of Blue Ocean Biomedical. Among his special skills: putting together the right team and creating an environment for success. Through his 30 years leadership, Mike has developed an extensive network of contacts and resources in the global diagnostic testing industry.
With a BA in Business Management and an MBA, Ernie has over 13 years in a variety of industries including biomedical, heavy machinery, and transportation logistics, where he gained extensive experience in business development, contract negotiations, logistics, and global sales forecasting. In 2001, Ernie became co-founder and executive VP of NPE Systems, where his responsibilities included strategic planning, product development and design, finance and manufacturing operations.
In 2009, Ernie became president of Blue Ocean Biomedical, where he is involved in all aspects of operations, with a leading role in strategic planning, finance, and product and business development. He combines extensive knowledge of the biomedical industry, especially cellular analysis systems, with all aspects of business management for a unique and valuable skill set.
After more than 25 years in marketing and product management with Coulter/Beckman Coulter, Willy has a strong background in cellular analysis instrumentation and in clinical and research applications, including HIV, immunology, hematology and oncology. He is a veteran of launching innovative systems, solutions and technologies. From marketing planning, to phased introduction of new systems, to taking products through the FDA clearance process, Willy has experienced all aspects of competing in the global clinical and research systems arena. Willy brings his valuable experience to bear on assessing new market opportunities and developing new, innovative product concepts to meet specific market needs.
Richard Thomas founded Ratcom Inc. in 1978 and then co-founded NPE Systems and later Blue Ocean Biomedical, where he serves as chairman of the board of directors and director of instrument systems development. He received multiple bachelor degrees from University of California at Berkeley in Physics, Mathematics, Biology, Chemistry and Biochemistry; and a Masters of Engineering Science degree from Florida State University in Biochemistry and Engineering Science. With this broad scientific education, Richard went on to develop a strong background in analog, digital, and power electronics design; software; optics; and mechanical engineering. As chief engineer, he has had a great deal of opportunity to apply his education and experience to the development of smart, efficient cell analysis systems.
Richard developed the NPE Flow Cell in 1998, a patented device for counting and sizing cells. He discovered and published the importance of Nuclear Packing Efficiency (NPE), a measure of the internal organizational structure of cells that enables a more detailed analysis of cell contents and abnormalities. In 1991, he was awarded a U.S. government contract to develop a flow cytometer for the international space station, in conjunction with an American Cancer Society grant to simultaneously develop a cytometer for the detection of cancer. As author of numerous US patents and scientific publications in the field of automated cellular analysis and related technologies, Richard provides a valuable resource to continuing development of instrumentation in these fields.
Mayra is a Certified Biomedical Auditor and Software Quality Engineer with 30 years of experience in validation, verification and quality systems management in the IVD industry. At Coulter Corporation, she gained extensive management experience in software development, validation and verification, and laboratory management. Now, at Blue Ocean, Mayra oversees a structured, quality-control process that complies with the requirements of ISO 13485, and leads to IVD product approvals and/or ISO certification for CE marking.
Marilyn has a well-rounded educational background with degrees in Accounting, Management, and Management Information Systems from Florida International University (FIU). With over 18 years of experience in all aspects of financial management and broad operations experience, Marilyn is a results-oriented controller and director of finance. At Blue Ocean, Marilyn’s responsibilities include: maintaining key strategic partnerships with suppliers and banking institutions, providing financial and management information systems, establishing internal financial safeguards, implementing financial processes, analyzing financial results, and identifying opportunities for improvement, cost reduction, and systems enhancement.
As a professional laboratory scientist, Raquel, who is a biochemist and immunologist, has been working for eight years with the NPE Systems and Blue Ocean development teams. In this role, she frequently collaborates with biomedical institutions such as the National Institute of Health (NIH), the University of Miami Miller School of Medicine, and Beth Israel (U. Mass, Boston). She is director of the Blue Ocean laboratory, overseeing laboratory people and projects, applications development, instrument validation and testing. Raquel’s many contributions include a wide knowledge of cell analysis applications, and a hands-on understanding of reagents and systems, quality control, sample preparation and protocols. Raquel is named as a coauthor on a number of published scientific articles and papers.
Tim Stiles is a manufacturing veteran with over 30 years of biomedical and scientific instrument manufacturing management experience from Coulter Corporation. As a focused factory manager, Tim was responsible for parts and inventory from cradle to grave: procurement, inventory management, warehousing, manufacturing, shipping, service, even repairs and reconditioning.
As director of manufacturing at Blue Ocean, Tim applies all that experience to keep the procurement and manufacturing operations running smoothly and to deliver a high-quality product. His responsibilities include day-to-day profit and loss operations for manufacturing, inventory control, reagent logistics, warehousing and service.
Orlando is a product development professional with strong expertise in flow cytometry reagents and applications. He has successfully managed projects in research and development, manufacturing, IT and more. His well rounded education includes a BS in Chemistry from the University of Miami, graduate studies at Barry University, as well as a Certificate in Project Management from FIU. He has more than 25 years of biomedical product experience with Coulter Corporation and Beckman Coulter Corporation, including introductions of diagnostic products within regulated environments (European IVDD/CE and US FDA 510 (k)). His experience with cGMP regulations and ISO compliance is an asset.
Orlando's previous roles have spanned from scientist (performing R&D of products and management of lab operations), to manufacturing manager of reagent operations, to IT manager implementing systems to support the operations, to program/project management of large, complex system projects.
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