Kathleen Walker Email & Phone Number
Executive Director Regulatory CMC @ Xencor
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Kathleen Walker Location
- California, United States
Kathleen Walker Work
- 2022 -now Executive Director Regulatory CMC @
- 2020 -now Senior Director, CMC Regulatory Affairs @
- 2019 -2020 Principal Consultant @
- 2016 -2018 Senior Director Chemistry, Manufacturing and Controls, Pharmaceutical Development @
- 2014 -2016 Site Head, Regulatory Affairs, Biologics CMC @
- 2008 -2014 Director Scientific Consulting @ Cardinal Health Specialty Solutions (Beckloff Associates)
- 2006 -2008 Director, Technical Operations @
- 2003 -2006 Director Technical Support @
- 1996 -2003 Assistant Director @
Kathleen Walker Education
- The Johns Hopkins University School of Pharmacology
Post Doctoral Fellow (Bioanalytical and High Resolution Mass Spectroscopy)
- University of California, San Diego
PhD (Physical Chemistry)
- University of California, Riverside
Post Doctoral Fellow
Kathleen Walker Skills
- Analytical Chemistry
- Biotechnology
- GMP
- FDA
- Product Development
- Pharmaceutical Industry
- Technical Operations
- IND
- Biosimilars
- Lifesciences
- Technology Transfer
- Validation
- GLP
- Pharmaceutical Development
- Analytical Development
- Drug Development
- Regulatory Affairs
- Regulatory Submissions
- Biologic Medicines
- SOP
- Biopharmaceuticals
- Life Sciences
- Clinical Trials
- Leadership
- Public Speaking
- Networking
- Data Analysis
- Regulatory
- Strategy
- SAN
- Microsoft Office
- Project Management
- Chemistry
- Cell Culture
- Teaching
- Contract Management
- Regulatory Filings
- High Performance Liquid Chromatography Hplc
- Technical Leadership
- Business Development
- Regulatory Risk
- Team Leadership
- Strategic Planning
- Regulatory Requirements
- Research and Development R&d
- CRO Management
- Strategic Leadership
- Pharmaceutics
- Cross Functional Team Leadership
- Cross Team Collaboration
- Manufacturing
- CMO management
- Situational Leadership
- Biologics
- Regulatory Strategy Development
- CMC
- Formulation
- Management
- CMO
- CMC Regulatory Affairs
- High Performance Liquid Chromatography
- Research and Development
Kathleen Walker Summary
- Kathleen Walker, based in California, United States, is currently a Executive Director Regulatory CMC at Xencor. Kathleen Walker brings experience from previous roles at Xencor, NDA Group AB, La Jolla Pharmaceutical Company and Gilead Sciences, Inc.. Kathleen Walker holds a Post Doctoral Fellow in Bioanalytical and High Resolution Mass Spectroscopy @ The Johns Hopkins University School of Pharmacology. With a robust skill set that includes Analytical Chemistry, Biotechnology, GMP, FDA, Product Development and more. Kathleen Walker has 2 emails and 4 mobile phone numbers on RocketReach.
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