Josh Kufera
Regulatory CMC | FDA Reviewer & Inspection Lead | Cell & Gene Therapy (Retro/Lenti, Integration Site Analysis SME)
- Role
- Gene Therapy Cmc Reviewer at FDA
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Josh Kufera
Primary reviewer for 100+ cell and gene therapy submissions across product lifecycle…
Experience
Gene Therapy Cmc Reviewer
May 2023 — Present · Washington, DC, US
Conduct scientific review & interpretation of product design, experimental results, and manufacturing data to evaluate the safety and quality of gene therapy products in regulatory submissions.• Conduct pre-license inspections of manufacturing and testing facilities as a product specialist.The Office of Gene Therapy (OGT) is located within the Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research (CBER).
Education
University of Oxford
Social Entrepreneurship
2014 — 2014
Christopher Newport University
Bachelor’s Degree
2012 — 2016
Spanish American Institute of International Education
Spanish Language and International Business
2015
The Johns Hopkins University School of Medicine
Doctor of Philosophy - PhD
2017 — 2022
Hereford High School
High School Diploma
2008 — 2012
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