Kathleen Walker
Executive Director, CMC Regulatory Affairs at Xencor
- Role
- Executive Director Regulatory Cmc at Xencor
- Location
- San Diego County, CA, US
- LinkedIn followers
- 500 followers
About Kathleen Walker
Experienced pharmaceutical professional with focus on Regulatory CMC and global regulatory submission experience. Previous hands-on experience in chemistry, manufacturing and controls (CMC). Demonstrated track record of success with regulatory submissions as well as in the pharmaceutical/biotechnology industry. Skilled in Regulatory CMC, Pharmaceutical Development, Technical Operations, Validation, GMP, and Biosimilars. Lead role in CMC development for many biologic and small molecule drug candidates across all phases of development. Regulatory CMC experience in global and North American regulatory strategy and submissions.
Experience
Executive Director Regulatory Cmc
Oct 2022 — Present
Education
University of California, San Diego
PhD, Physical Chemistry
The Johns Hopkins University School of Pharmacology
Post Doctoral Fellow, Bioanalytical and High Resolution Mass Spectroscopy
University of California, Riverside
Post Doctoral Fellow, Bioanalytical and High Resolution Mass Spectroscopy
Skills
- Analytical Chemistry
- Biologic Medicines
- Life Sciences
- Product Development
- Technology Transfer
- Biotechnology
- Technical Operations
- Gmp
- Regulatory Submissions
- Analytical Development
- Validation
- Regulatory Affairs
- Lifesciences
- Drug Development
- Biopharmaceuticals
- Glp
- Ind
- Biosimilars
- Clinical Trials
- Pharmaceutical Industry
- Sop
- Fda
- Pharmaceutical Development
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