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Amy Hsu Email & Phone Number

Senior CMC Reviewer for Biotechnology Products at FDA at FDA

Location: Washington Dc-Baltimore Area, United States 6 work roles 2 schools

1 work email found @fda.gov LinkedIn matched

✓ Verified Jul 2026 4 data sources Profile completeness 100%

Current company

FDA

Role

Senior CMC Reviewer for Biotechnology Products at FDA

Location

Washington Dc-Baltimore Area, United States

Company size

14770 employees

Who is Amy Hsu? Overview

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Quick answer

Amy Hsu is listed as Senior CMC Reviewer for Biotechnology Products at FDA at FDA, a with 14770 employees, based in Washington Dc-Baltimore Area, United States. AeroLeads shows a work email signal at fda.gov and a matched LinkedIn profile for Amy Hsu.

Amy Hsu previously worked as Senior Chemist at Fda and Product Quality Reviewer for Biotechnology Products at Fda. Amy Hsu holds Bs, Chemistry from National Taiwan University.

Company email context

Email format at FDA

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{first}.{last}@fda.gov

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AeroLeads found 1 current-domain work email signal for Amy Hsu. Compare company email patterns before reaching out.

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Profile bio

About Amy Hsu

• Interested in quality and risk assessment of medical products. • Creative strategic planning, decision-making, and forward thinking abilities. • Passionate team player with effective interpersonal and time management skills. • Proficient in communication, writing, and presentation.

Listed skills include Molecular Biology, Protein Chemistry, Cell Culture, Biochemistry, and 11 others.

Current workplace

Amy Hsu's current company

Company context helps verify the profile and gives searchers a useful next step.

Fda

Senior CMC Reviewer for Biotechnology Products at FDA

silver spring, maryland, united states

Website

fda.gov

Employees

14770

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Company profile

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6 roles

Amy Hsu work experience

A career timeline built from the work history available for this profile.

Senior Chemist

Current

Fda

Sep 2022 - Present

Product Quality Reviewer For Biotechnology Products

Current

Fda

Silver Spring, Maryland

Responsible for CMC/product quality assessment and facility inspection (IND, BLA) of therapeutic biologic and biosimilar products at the CDER Office of Biotechnology Products.

May 2018 - Present

Orise Research Fellow

Fda

Silver Spring, Maryland

Developed and validated multiple (Q)SAR/in silico toxicology approaches to assess the genotoxic and carcinogenic potential of drug components (i.e., API, impurities, leachables, extractables, degradents).

Nov 2017 - May 2018

Commissioner'S Fellow

Fda

Silver Springs, Md

Provided computational toxicology consultation reviews to CDER review teams in support of safety and quality review of new and generic drug products (IND, NDA, ANDA, DMF).Conducted clinical pharmacology research to expedite product development and regulatory review of antiviral medical countermeasure (MCM) products.

Nov 2015 - Nov 2017

Postdoctoral Research Associate

National Institutes Of Health

Rockville, Md

National Center for Advancing Translational Sciences (NCATS):Developed and validated in vitro assays and computational studies to profile the toxicity effects/mechanisms of the Tox21 10K environmental chemicals and repurpose approved drugs for oncology drug development.

Dec 2012 - Nov 2015

Research Assistant

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina

Prepared and characterized various protein scaffolds and fluorescent conjugates for binding of intracellular targets and for quantification of spatial and temporal protein activities in single living cells.

Jul 2007 - Dec 2012

Team & coworkers

Colleagues at FDA

Other employees you can reach at fda.gov. View company contacts for 14770 employees →

CO

Casmir Ogbonna, Pharmd, Mba, Bcps, Bcgp, Cph Colleague at FdaSilver Spring, Maryland, United States View → KB

Katelyn Bittleman Colleague at FdaSilver Spring, Maryland, United States View → DK

Devin Koontz Colleague at FdaGreenwood, Missouri, United States View → DR

Debbie Racioppi Colleague at FdaWinter Garden, Florida, United States View → TC

Troy Cu Colleague at FdaFairfax, Virginia, United States View → GP

Gisa Perez Colleague at FdaWashington Dc-Baltimore Area, United States View → VM

Vedrath Murthy Colleague at FdaNew York City Metropolitan Area, United States View → SC

Sharon Campbell Colleague at FdaManassas, Virginia, United States View → LM

Lauren Milligan Colleague at FdaSavage, Maryland, United States View → SH

Shauntise Holmes Colleague at FdaSilver Spring, Maryland, United States View →

2 education records

Amy Hsu education

Bs, Chemistry

National Taiwan University

Phd, Pharmaceutical Sciences

University Of North Carolina At Chapel Hill

FAQ

Frequently asked questions about Amy Hsu

Quick answers generated from the profile data available on this page.

What company does Amy Hsu work for?

Amy Hsu works for FDA.

What is Amy Hsu's role at FDA?

Amy Hsu is listed as Senior CMC Reviewer for Biotechnology Products at FDA at FDA.

What is Amy Hsu's email address?

AeroLeads has found 1 work email signal at @fda.gov for Amy Hsu at FDA.

Where is Amy Hsu based?

Amy Hsu is based in Washington Dc-Baltimore Area, United States while working with FDA.

What companies has Amy Hsu worked for?

Amy Hsu has worked for Fda, National Institutes Of Health, and University Of North Carolina At Chapel Hill.

Who are Amy Hsu's colleagues at FDA?

Amy Hsu's colleagues at FDA include Casmir Ogbonna, Pharmd, Mba, Bcps, Bcgp, Cph, Katelyn Bittleman, Devin Koontz, Debbie Racioppi, and Troy Cu.

How can I contact Amy Hsu?

You can use AeroLeads to view verified contact signals for Amy Hsu at FDA, including work email, phone, and LinkedIn data when available.

What schools did Amy Hsu attend?

Amy Hsu holds Bs, Chemistry from National Taiwan University.

What skills is Amy Hsu known for?

Amy Hsu is listed with skills including Molecular Biology, Protein Chemistry, Cell Culture, Biochemistry, Assay Development, Pharmacology, Organic Synthesis, and Drug Discovery.

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