Team Lead, Gene Therapy CMC @ (March 2022 - September 2023)
Cell and Gene Therapy CMC Reviewer @ (September 2018 - February 2022)
Interagency Oncology Task Force (IOTF), Researcher and Regulatory Reviewer @ (September 2017 - August 2018)
ORISE Researcher @ (June 2014 - August 2017)
Graduate Student Researcher @ (January 2008 - January 2014)
Andrew Harmon Education
UCLA
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 @ UCLA. 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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