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Proven track record in developing clinical IVD quantitative immunoassays for biomarkers on several automated analyzers and on manual ELISA microplate. Demonstrated excellence in the development of market leading cardiac biomarker assays such as cardiac troponin I (cTnI) and B-Natriuretic peptide (BNP).
Stephen P Chan
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Ivd Assay Development Principal ConsultantStephen P Chan Apr 2014 - PresentGreater Minneapolis-St. Paul AreaProvides consulting to the Medical Device Industry. Services include IVD immunoassay development, problem solving for manufacturing, regulatory, quality and customer issues resolution, compliance to FDA and ISO regulatory organizations.
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Staff ScientistBeckman Coulter Inc Mar 1988 - Apr 2014Greater Minneapolis-St. Paul AreaChief Scientist in Product Development & Product Support for high revenue immunoassays for cardiac, cancer, endocrine and anemia diseases.Managed clinical IVD product development teams from conception to commercialization through Design Control process. Consult and support across cross-functional business units including Regulatory, Clinical, Quality Assurance, Quality Control, Marketing, Customer Support, Supply Chain and Manufacturing.Ensured compliance to Quality System… Show more Chief Scientist in Product Development & Product Support for high revenue immunoassays for cardiac, cancer, endocrine and anemia diseases.Managed clinical IVD product development teams from conception to commercialization through Design Control process. Consult and support across cross-functional business units including Regulatory, Clinical, Quality Assurance, Quality Control, Marketing, Customer Support, Supply Chain and Manufacturing.Ensured compliance to Quality System Regulations.Technical Review Board member to asses New Product Development.Principal Technical Lead responsible for scientific evaluation & collaboration with OEM business partners in US, Europe and Japan. Project Lead for the OEM development of several high revenue allergy blood tests. Show less -
Post-Doctoral Research AssociateUniversity Of Minnesota Sep 1984 - Mar 1988Researched on a murine model of chronic viral infection in the Central Nervous System to understand the pathogenesis of lactate dehydrogenase elevating virus, which causes paralysis and mortality in several in-bred strainsSpecialized in the immunofluorescence /dual labeling for the localization of viral proteins and cell-specific markersProduction and characterization of monoclonal antibodies to virus proteins -
Medical Laboratory Scientific OfficerCleveland General Hospital & Public Health Laboratory, Uk Aug 1978 - Jul 1979Conducted routine bacterial, fungal & parasite cultures and pathogen identification, and viral serology, culture and identification. Conducted bacterial contamination monitoring of water and food for Public Health Service.
Stephen P Chan Skills
Stephen P Chan Education Details
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Virology And Immunobiology -
Medical Science (Microbiology Major) -
Raimondi College
Frequently Asked Questions about Stephen P Chan
What company does Stephen P Chan work for?
Stephen P Chan works for Stephen P Chan
What is Stephen P Chan's role at the current company?
Stephen P Chan's current role is IVD Assay Development Consultant at Stephen P Chan.
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What schools did Stephen P Chan attend?
Stephen P Chan attended Queen's University Belfast, University Of Bradford, Raimondi College.
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Stephen P Chan has skills like Data Mining, Statistics, Analytics, Jmp, Problem Solving, Dmaic, Predictive Modeling, Six Sigma, Data Analysis, Doe, Design Of Experiments, Predictive Analytics.
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Stephen P. Chan
Executive Director, Legal & Compliance At Anbang Overseas Holdings Co. LimitedHong Kong Sar
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