Roy Chen Email & Phone Number | Eighteen years of managing and development of reagents for Flowcytometry systems and medical diagnostics. • Developed reagent products from concept stage to market launch, >10 products FDA 510k cleared • Scaled up processes to achieve manufacturing reproducibility, interacted with Operations to successfully validate and transfer processes • Supported software development in testing of software before release • Supported customer-facingt functions in resolving complaints • Supported product registrations with US FDA, China FDA, Brazil ANVISA, Indonesia , Korea and other foreign government registrations. Revenues impact of 70 million and 14 million respectively associated with China FDA and Brazil ANVISA registrations • Co-authored 4 patents and 20 plus publications

Roy Chen

Eighteen years of managing and development of reagents for Flowcytometry systems and medical diagnos...
San Jose, California, United States

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Roy Chen’s Email roy_chen@bd.com

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Roy Chen’s Location San Jose, California, United States

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Roy Chen’s Prior Industry Bd Biosciences | Hycor Biomedical | Syva

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Associate Director, Reagent Development

1998-05-01 00:00:00 - 2016-12-01 00:00:00

R&D Program Manager

1996-05-01 00:00:00 - 1998-04-01 00:00:00

R&D Group Leader

1994-09-01 00:00:00 - 1996-09-01 00:00:00

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Roy Chen is a Eighteen years of managing and development of reagents for Flowcytometry systems and medical diagnostics. • Developed reagent products from concept stage to market launch, >10 products FDA 510k cleared • Scaled up processes to achieve manufacturing reproducibility, interacted with Operations to successfully validate and transfer processes • Supported software development in testing of software before release • Supported customer-facingt functions in resolving complaints • Supported product registrations with US FDA, China FDA, Brazil ANVISA, Indonesia , Korea and other foreign government registrations. Revenues impact of 70 million and 14 million respectively associated with China FDA and Brazil ANVISA registrations • Co-authored 4 patents and 20 plus publications