Tania R.
CMC Reviewer at The FDA, Gene Therapy
- Role
- Cmc Reviewer at FDA
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Tania R.
A skilled professional in bioprocess development and regulatory affairs and is currently serving as a CMC Reviewer at the Food & Drug Administration (FDA). At the FDA, I have contributed to the CMC review of multiple in-vivo gene therapy products at various stages of development, from early pre-clinical phases to post-marketing evaluations.Previously, as the Associate Director of Process Development at StrideBio, I led and mentored cross-functional teams to develop and transfer new AAV based therapeutics from lab to manufacturing. My expertise also includes the downstream process development of monoclonal antibodies and Fc fusion proteins, and leading interactions with various clients at a CDMO, KBI Biopharma. I have authored numerous technical documents and research plans, driven by a commitment to quality and innovation in the biopharmaceutical field.
Experience
Cmc Reviewer
Jun 2023 — Present
Education
Rensselaer Polytechnic Institute
Doctor of Philosophy (PhD), Chemical Engineering
2012 — 2015
Institute Of Chemical Technology
Bachelor of Technology (B.Tech.), Pharmaceutical Sciences & Technology
2008 — 2012
Georgia Institute of Technology
Doctor of Philosophy (PhD) (Current), Chemical and Biomolecular Engineering
2015 — 2017
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