Melissa Varner
Principal Consultant, CMC Operations and Project Management
- Role
- Principal Consultant, Cmc and Program Management at The Sp Group
- Location
- Erie, CO, US
- LinkedIn followers
- 500 followers
About Melissa Varner
Experienced Director Of CMC development with a demonstrated history of working in the early-phase pharmaceutical development. Skilled in CMC operations, oversight of external DS and DP manufacturing, and interacting with US and ex-US regulatory bodies. Other skills include supporting Process Development, CMC Writing, Quality Operations, and Analytical Development. Strong program and project management professional with a Ph.D. focused in Synthetic Organic Chemistry from the University of Kentucky.
Experience
Principal Consultant, Cmc and Program Management
Apr 2023 — Present · Denver, CO, US
CMC PM Consultant for biologics portfolio, ADC (mAb, L-P, ADC DS and DP) bsAb/TCE DS/DP manufacturingPortfolio budget managementCMO Oversight
Education
West Virginia University
B.S., Chemistry
1990 — 1994
University of Kentucky
Ph.D., Synthetic Organic Chemistry
1994 — 1999
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