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Michael Louie Location
San Mateo, CA, US
Michael Louie Work
SVP Digital Transformation, Chief Information Officer @ (February 2022 - Present)
Vice President, Analytical Operations & Information Systems @ (July 2019 - January 2022)
Vice President, Information Technology @ (February 2016 - July 2019)
Senior Director, Information Technology @ (February 2010 - January 2016)
Scientist @ (January 1992 - January 1993)
Analytical Chemist @ Syntex Corporation (June 1986 - August 1987)
Michael Louie Skills
21 CFR Part 11
Agile Application Development
Analytical Chemistry
Biopharmaceuticals
CAPA
CTMS
Chromatography
Clinical Data Management
Clinical Development
Cloud Computing
Computer System Validation
Cross-functional Team Leadership
Data Management
Document Management
Documentum
Drug Development
EDC
Enterprise Resource Planning (ERP)
Formulation
GCP
GLP
GxP
Infectious Diseases
Informatics
Information Security
LC-MS
LIMS
Laboratory Automation
Manufacturing
NDA
Oncology
Organic Chemistry
Pharmacovigilance
Quality Assurance
Quality System
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Risk Based Audits
Risk Management
SDLC
Supply Chain Management
Technology Transfer
Validation
Vendor Management
eCTD
Michael Louie Summary
Michael Louie, based in San Mateo, CA, US, is currently a SVP Digital Transformation, Chief Information Officer at Kodiak Sciences. Michael Louie brings experience from previous roles at Gilead Sciences and Monsanto. With a robust skill set that includes 21 CFR Part 11, Agile Application Development, Analytical Chemistry, Biopharmaceuticals, CAPA and more. Michael Louie has 1 emails on RocketReach.
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