Shannon Holmes
VP, Cmc Regulatory and Quality @Invivyd
Signup · Get unlimited contacts
WORK HISTORY
VP, Cmc Regulatory and Quality @Invivyd
EDUCATION
The University of North Carolina at Chapel Hill
Ph.D., Biological Chemistry
Davidson College
B.S., Chemistry
SKILLS
ABOUT SHANNON HOLMES
Experienced Regulatory CMC leader across modalities (gene therapies, biologics, anti-sense oligonucleotides [ASOs], small molecules, and combination products) at various stages of development (Phase 1 through post-approval) Experienced Quality leader (GMP, GDP, GCP, GLP, and GVP) providing phase-appropriate guidance and leadership rooted in quality risk management and quality by design principles Lead and participate in executive discussions regarding strategic quality and regulatory pathways and decisions Lead business development activities and project feasibility, including quality and regulatory assessments for emergency use, fast track, orphan indications, and complex drug development pathways
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.