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Kathy Simon Location
Raleigh, NC, US
Kathy Simon Work
Vice President Global Quality @ (June 2024 - Present)
Head of Quality Gene Therapy @ (June 2023 - May 2024)
Adjunct Faculty Instructor @ (November 2015 - June 2023)
Vice President Quality Control @ Medicago (April 2021 - April 2023)
Senior Director Network Strategy @ (September 2020 - April 2021)
Global Quality Management System @ (October 2018 - September 2020)
Director Quality Operations @ (January 2013 - October 2018)
Head of Manufacturing @ Diosynth (February 2010 - January 2013)
Director Upstream Processing and Development @ Diosynth (May 2009 - February 2010)
Associate Director Regulatory Compliance @ Diosynth (December 2007 - May 2009)
Manager, Worldwide Regulatory CMC @ (January 2004 - January 2006)
Quality @ (January 1999 - January 2001)
Kathy Simon Education
Virginia Tech
PhD (Biochemistry)
1992-1996
George Mason University
BS (Biology)
1988-1992
Kathy Simon Skills
Analytical Skills
Aseptic Processing
Biopharmaceuticals
Biotechnology
CAPA
Change Control
Chromatography
Contract Manufacturing
FDA
Fermentation
GLP
GxP
LIMS
Leadership
Life Sciences
Lifesciences
Manufacturing Operations
Medical Devices
Monoclonal Antibodies
Operational Planning
Performance Motivation
Pharmaceutical Industry
Project Management
Protein Chemistry
Purification
Quality Assurance
Quality System
Reasoning Skills
Regulatory Affairs
Regulatory Compliance
Regulatory Submissions
SOP
Strategic Thinking
Technology Transfer
Thinking Skills
V&V
Vaccines
Validation
Kathy Simon Summary
Kathy Simon, based in Raleigh, NC, US, is currently a Vice President Global Quality at Cellectis. Kathy Simon brings experience from previous roles at Catalent Pharma Solutions, Duke University, Medicago and CSL Behring. Kathy Simon holds a 1992 - 1996 PhD in Biochemistry @ Virginia Tech. With a robust skill set that includes Analytical Skills, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA and more. Kathy Simon has 2 emails and 1 mobile phone numbers on RocketReach.
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