Linda O Narhi, PhD
Biological Chemistry – UCLA
Biotherapeutic Development
Expertise: :
Biotherapeutic development, particles, protein conformational analysis, manufacturability assessment/candidate selection, Target Product Profile, Quality by Design
Experience:
over 35 years in Biotherapeutic Development, primarily at Amgen (retired as Scientific Executive Director). Led Protein higher order structure analysis and particle labs, Postdoc program and Educational Outreach for Process Development organization (PD), editor for internal PD journal (Galenics), co-lead for cross functional protein engineering and manufacturability assessment teams (with R&D).
Other:
Adjunct Prof at UC Santa Barbara, co-chair Bioengineering Institute of California Industry Liaison Committee, USP volunteer (including current chair of Subvisible particle expert panel), founding member of IQ consortium Biologics CMC leadership group, AAPS Fellow, AIMBE Fellow