Kelsey Hoontis's Location
United States
Kelsey Hoontis's Work
- Associate Director Global Regulatory Affairs-CMC @ Novavax
- Manager Global Regulatory Affairs -Biological Vaccines-CMC and CDMO space- @ Emergent BioSolutions
- Regulatory Consultant @ Bird Rock Bio, Inc.
- Manager- Global Regulatory Affairs- CMC-Small Molecules and Biologics @ Shire
- Specialist-Global Regulatory Affairs- Immunology- -Immuno-Oncology Pipeline) @ EMD Serono, Inc.
- Sr. Associate- Global Regulatory Affairs-CMC @ Sanofi
- Associate II- Global Regulatory Affairs- CMC @ Sanofi
- Sr. Compliance Associate (CMC - Rare Disease Biologic) @ Sanofi
- Lead Compliance Investigator (CMC- Rare Disease Biologic) @ Sanofi
- Bio-Process Associate (Clinical Operations- Biologic) @ Gilead Sciences
Kelsey Hoontis's Education
- The London School of Economics and Political Science (LSE)
Certificate (Master of Bussiness Administration Essentials)
2021 - 2021 - Northeastern University
Master of Science - MS (Regulatory Affairs, of Drugs, Biologics and Medical Devices)
2011 - 2014 - University of New Hampshire
Bachelor of Science - BS (Nutritional Science)
2001 - 2005
Kelsey Hoontis's Skills
- Biotechnology
- CAPA
- FDA
- Change Control
- GMP
- Biopharmaceuticals
- 21 CFR Part 11
- Regulatory Affairs
- Regulatory Submissions
- Pharmaceutical Industry
Kelsey Hoontis's Summary
Kelsey Hoontis, based in United States, is currently a Associate Director Global Regulatory Affairs-CMC at NOVAVAX INC, bringing experience from previous roles at Emergent BioSolutions, Bird Rock Bio, Inc., Shire and EMD Serono, Inc.. Kelsey Hoontis holds a 2021 - 2021 Certificate in Master of Bussiness Administration Essentials @ The London School of Economics and Political Science (LSE). With a robust skill set that includes Biotechnology, CAPA, FDA, Change Control, GMP and more, Kelsey Hoontis contributes valuable insights to the industry. Kelsey Hoontis has 2 emails on RocketReach.
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