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Kathleen Walker
Kathleen Walker
Executive Director Regulatory CMC | Xencor
California, United States
Kathleen Walker
Summary
Kathleen Walker is an accomplished Executive Director specializing in CMC Regulatory Affairs within the biotechnology sector. With a robust background in analytical chemistry and a proven track record in regulatory submissions, she has successfully led CMC development for both biologic and small molecule drug candidates. Her expertise spans across various stages of drug development, emphasizing compliance with global regulatory standards. Kathleen has held leadership roles in several prominent organizations, showcasing her ability to navigate complex regulatory landscapes. Her strategic mindset is complemented by a strong focus on cross-functional collaboration and team leadership. Kathleen is passionate about advancing pharmaceutical innovation and ensuring the safe delivery of new therapies to patients. Outside of her professional pursuits, she is likely to be involved in mentoring the next generation of scientists and regulatory professionals.
Kathleen Walker
Work Experience
Executive Director Regulatory CMC at
Xencor
October 2022 - Present
Senior Director, CMC Regulatory Affairs at
Xencor
January 2020 - Present
Principal Consultant at
NDA Group - an SSI Strategy Company
January 2019 - January 2020
Senior Director Chemistry, Manufacturing and Controls, Pharmaceutical Development at
La Jolla Pharmaceutical Company
January 2016 - January 2018
Site Head, Regulatory Affairs, Biologics CMC at
Gilead Sciences Austria
January 2014 - January 2016
Director Scientific Consulting at
Cardinal Health Specialty Solutions
January 2008 - January 2014
Director, Technical Operations at
HI-EISAI PHARMACEUTICAL, INC.
January 2006 - January 2008
Director Technical Support at
Ligand Pharmaceuticals
January 2003 - January 2006
Assistant Director at
Ionis Pharmaceuticals, Inc.
January 1996 - January 2003
Kathleen Walker
Education
The Johns Hopkins University School of Pharmacology, Post Doctoral Fellow
University of California, Riverside, Post Doctoral Fellow
Frequently Asked Questions about Kathleen Walker
What is Kathleen Walker email address?
Kathleen Walker's primary email address is *******@xencor.com. To view the full verified email and additional contact details, sign up for free with Muraena.
What company does Kathleen Walker work for?
Kathleen Walker is a Executive Director Regulatory CMC at Xencor, a company specializing in Commercial physical research.
Where Kathleen Walker graduated from?
Kathleen Walker holds a degree in Bioanalytical And High Resolution Mass Spectroscopy from The Johns Hopkins University School of Pharmacology.
How can I directly contact Kathleen Walker?
To contact Kathleen Walker directly, you can use the email address *******@xencor.com. Complete contact information is available upon registration with Muraena.
Who is Kathleen Walker?
Kathleen Walker is an accomplished Executive Director specializing in CMC Regulatory Affairs within the biotechnology sector. With a robust background in analytical chemistry and a proven track record in regulatory submissions, she has successfully led CMC development for both biologic and small molecule drug candidates. Her expertise spans across various stages of drug development, emphasizing compliance with global regulatory standards. Kathleen has held leadership roles in several prominent organizations, showcasing her ability to navigate complex regulatory landscapes. Her strategic mindset is complemented by a strong focus on cross-functional collaboration and team leadership. Kathleen is passionate about advancing pharmaceutical innovation and ensuring the safe delivery of new therapies to patients. Outside of her professional pursuits, she is likely to be involved in mentoring the next generation of scientists and regulatory professionals.
Kathleen`s contact details
*******@xencor.com
*******@ljpc.com
*******@abac.com
Colleagues
Vice President, Head of Clinical Operations
Patent Attorney (retired but consulting for Xencor)
Sr. Vice President Regulatory Affairs and Quality Assurance
Executive Director, Nonclinical and Bioanalytical Development
Vice President, Program Leadership and Strategic Alliances
Executive Director, Human Resources
Vice President, Biometrics
Vice President
Executive Director, CMC Operations – Drug Product and Supply Chain
VP Discovery Biology and Pharmacology