Victor J. Gangi
Vice President, Regulatory Affairs CMC at Zenas BioPharma- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Experience
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Zenas BioPharma
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United States
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Biotechnology Research
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1 - 100 Employee
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Vice President, Regulatory Affairs CMC
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Jan 2022 - Present
Global Head of Regulatory Affairs CMC for Zenas Biopharma. Responsible for advising, developing, leading and executing RA CMC strategy for all products in the company pipeline. Regulatory co-lead for multiple China regulatory programs in clinical development.
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Executive Director, Regulatory Affairs CMC
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May 2021 - Jan 2022
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Sr. Director, CMC Regulatory Affairs
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Jan 2020 - May 2021
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TESARO, Inc.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Director, Regulatory CMC
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Nov 2016 - Jan 2020
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Associate Vice President, Regulatory CMC Biologics
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Oct 2015 - Nov 2016
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Sr. Director Global Regulatory Affairs CMC Biologics
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Aug 2014 - Oct 2015
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Senior Director, Regulatory Affairs CMC
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Jun 2012 - Aug 2014
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Director, Global CMC Regulatory
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Oct 2009 - Jun 2012
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Director, Global Regulatory Affairs CMC
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Jun 2008 - Oct 2009
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Director, Regulatory Affairs CMC
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Feb 2006 - Jun 2008
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Biogen
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United States
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Biotechnology Research
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700 & Above Employee
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Associate Director, Regulatory Affairs CMC
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Nov 2000 - Feb 2006
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FDA
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United States
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Government Administration
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700 & Above Employee
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Investigator
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Aug 1997 - Nov 2000
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Microbiologist
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Jan 1992 - Aug 2000
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Education
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University of Southern California
DRSc, Regulatory Science -
University of Southern California
Master's degree, Regulatory Science -
University of Massachusetts Lowell
MS, Biology -
University of Massachusetts Amherst
BS, Microbiology -
Florida Institute of Technology
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