Kate Nelson
Bio-pharmaceutical leader with experience in both Large and Small Molecules and Drug/Device Combination Products
- Role
- Vice President Technical Operations at Electra Therapeutics
- Location
- Redwood City, CA, US
- LinkedIn followers
- 500 followers
About Kate Nelson
Lean Production Systems, Design for Reliability and Manufacturability (DRM), Lean Six Sigma, Design Verification and Validation, Process Validation, Design of Experiments (DOE), Statistical Process Control (SPC), Root Cause Analysis, FMEA, ISO 13485, IDE submissions, IND submissions, PMA submissions and BLA submissions, FDA\'s QSR for Medical Devices, cGMP for PharmaceuticalsParenteral Drug Association (PDA) West Coast Chapter board member 20••••20
Experience
Vice President Technical Operations
Nov 2024 — Present · South San Francisco, CA, US
Education
University of Massachusetts Amherst
MS, Polymer Science and Engineering
Mount Holyoke College
BA (high honors), Chemistry
Skills
- U.s. Food and Drug Administration (Fda)
- Design of Experiments
- Manufacturing
- Iso 13485
- Six Sigma
- Dmaic
- Quality Assurance
- Polymer Chemistry
- Root Cause Analysis
- Hplc
- Polymers
- Minitab
- Mathematica
- Optical Microscopy
- Medical Devices
- Capa
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Gmp
- R&D
- Polymer Characterization
- Materials Science
- Tem
- Afm
- Xps
- Research and Development (R&D)
- Cqe
- Fmea
- Fda
- Tga
- Quality System
- Surface Chemistry
- Spc
- Corrective and Preventive Action (Capa)
- Ellipsometry
- Quality Management
- Iso 14971
- Nmr
- Instron
- Validation
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