
David Keire
Research Scientist

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About me
Office Director of the Office of Testing and Research at US FDA
Education

University of Washington
1981 - 1985BS ChemistryBS in Chemistry

University of California, Riverside
1985 - 1990PhD Analytical ChemistryPhD in Analytical Chemistry from Dallas Rabenstein specializing in NMR spectroscopy.
Experience

City of Hope
Jan 1992 - Jan 1999Research Scientist
UCLA Medical School
Jan 1999 - Sept 2008Senior ResearcherAt UCLA I performed analytical work on peptide hormones released in the gut with food intake. These hormones were satiety and hunger behavior related peptides. The work involved purification and quantification of the forms and levels of several hormones, including CCK, PYY and GLP-1. Primary analysis tools were LC-MS and radioimmunoassay. In addition NMR spectroscopy was used to assess the solution tertiary structure of the peptide forms found to be present in tissue and blood.

FDA
Oct 2008 - nowAs a Branch Chief I had 17 full time equivalent (FTEs) employees and 8 contract employees that report to me. My reports perform analytical work in the area of dissolution, inhalation, transdermals, heparin related drugs, method verification protocol evaluation and regulatory sample testing. In addition, I have a research program in the area of complex drug evaluation by emerging analytical technologies. I am a subject matter expert on heparin drugs for the agency and serve on USP expert panels for monograph development on heparin drugs and glatiramer acetate. Show less
Office Director CDER/OPQ/OTR
Jun 2021 - nowDeputy Office Director CDER/OPQ/OTR
Sept 2019 - May 2021Division Director
Jan 2017 - Aug 2019Acting Laboratory Chief
Jan 2015 - Jan 2017Research Chemist
Oct 2008 - Dec 2014
Licenses & Certifications
- View certificate

Accelerating Change Readiness & Agility
University of California, Berkeley, Haas School of BusinessOct 2017
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