Michelle O'Brien Email & Phone Number
Executive Director, Regulatory CMC @ Xenon Pharmaceuticals Inc.
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Michelle O'Brien Location
- Boston, MA, US
Michelle O'Brien Work
- Executive Director, Regulatory CMC @ (January 2026 - Present)
- Senior Director, Regulatory Affairs CMC @ (March 2024 - January 2026)
- Director, Regulatory Affairs CMC @ (June 2022 - March 2024)
- Director Global Regulatory Affairs CMC @ (October 2021 - June 2022)
- Associate Director Regulatory Affairs @ (March 2016 - October 2021)
- Senior Manager, Regulatory Affairs @ (May 2012 - March 2016)
- Senior Manager, Quality Assurance @ (January 2008 - May 2012)
- Manger, Quality Assurance @ (March 2007 - January 2008)
- Quality Assurance Manager @ Cambridge Isotope Labs (January 2005 - January 2007)
Michelle O'Brien Education
- Boston University
BA (MA, Chemistry)
1986-1990
Michelle O'Brien Skills
- GMP
- CAPA
- FDA
- Validation
- Change Control
- Pharmaceutical Industry
- GxP
- Quality Assurance
- Regulatory Affairs
- 21 CFR Part 11
- Sop
- Trackwise
- IND
- GLP
- Technology Transfer
- Regulatory Submissions
- Quality System
- CMC
- CMC Regulatory Affairs
- New Drug Application (NDA)
- Research
- Microsoft Excel
- Process Improvement
- New Drug Application Nda
- New Drug Application
Michelle O'Brien Summary
- Michelle O'Brien, based in Boston, MA, US, is currently a Executive Director, Regulatory CMC at Xenon Pharmaceuticals Inc.. Michelle O'Brien brings experience from previous roles at Xenon Pharmaceuticals Inc. and Biogen. Michelle O'Brien holds a 1986 - 1990 BA in MA, Chemistry @ Boston University. With a robust skill set that includes GMP, CAPA, FDA, Validation, Change Control and more. Michelle O'Brien has 1 emails and 2 mobile phone numbers on RocketReach.
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Top Xenon Pharmaceuticals Inc. Employees
James Empfield
Exe. VP, Drug Discovery
Waltham, MA, US
John Kuczek
SVP, Pharmaceutical Sciences and Manufacturing
Lowell, MA, US
Tucker Kelly
Chief Financial Officer
Concord, MA, US
Robin Sherrington
Executive Vice President Strategy and Innovation
North Vancouver, BC, CA
Mark Benvenuto
SVP Portfolio and Alliance Management
Boston, MA, US
Matthew Ronsheim
Chief Operating Officer
Boston, MA, US
Ian Mortimer
President and CEO
North Vancouver, BC, CA
Lee Gervitz
SVP Medical Affairs
Boston, MA, US
John Holyoake
Vice President, Business Development
Vancouver, BC, CA
Shelley McCloskey
Executive Vice President Human Resources
Vancouver, BC, CA
Alix Helper
Commercial Vice President
Vancouver, BC, CA
Greg Beatch
VP, Clinical Development
Vancouver, BC, CA
Jp Johnson Jr.
SVP, Biology
Vancouver, BC, CA
Ilona Lo
Vice President, Finance
Vancouver, BC, CA
Andrea Difabio
Chief Legal Officer and Corporate Secretary
Boston, MA, US
Alison Cutts
Vice President, Scientific Affairs
Nelson, BC, CA
Darren Cline
Chief Commercial Officer
Kirkland, WA, US
Chris Kenney
Chief Medical Officer
Boston, MA, US
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