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Andrew Harmon Location
South Bend, IN, US
Andrew Harmon Work
2023 -now Chief, Gene Therapy Branch 1 @
2022 -2023 Team Lead, Gene Therapy CMC @
2018 -2022 Cell and Gene Therapy CMC Reviewer @
2017 -2018 Interagency Oncology Task Force (IOTF), Researcher and Regulatory Reviewer @
2014 -2017 ORISE Researcher @
2008 -2014 Graduate Student Researcher @
Andrew Harmon Education
University of California, Los Angeles
Ph.D. (Molecular, Cell, and Developmental Biology)
2008-2014
University of Delaware
B.S. (Cell and Molecular Biology, Genetics)
2004-2008
Andrew Harmon Skills
AAV Vector Gene Therapy
Biologics Development
CMC Regulatory Affairs
U.S. Food and Drug Administration (FDA)
Gene Therapy
Regulatory Affairs
Regulatory Submissions
Product Development
Oncology
Product Quality
Regulatory Writing
Advanced Therapies
Viral Vectors
Electronic Common Technical Document (eCTD)
Immuno Oncology
Cell Therapy
Biologics
Orphan Drugs
Common Technical Document (CTD)
IND
eCTD
Regenerative Medicine
RMAT
CMC
Chemistry, Manufacturing, and Contols
Scientific Communications
Andrew Harmon Summary
Andrew Harmon, based in South Bend, IN, US, is currently a Chief, Gene Therapy Branch 1 at FDA. Andrew Harmon brings experience from previous roles at FDA. Andrew Harmon holds a 2008 - 2014 Ph.D. in Molecular, Cell, and Developmental Biology @ University of California, Los Angeles. With a robust skill set that includes AAV Vector Gene Therapy, Biologics Development, CMC Regulatory Affairs, U.S. Food and Drug Administration (FDA), Gene Therapy and more. Andrew Harmon has 5 emails and 3 mobile phone numbers on RocketReach.
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