Rebecca Gentile
- Role
- Associate Director at Merck
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Rebecca Gentile
Pharmaceutical professional with over 20 years of Quality organization experience…
Experience
Associate Director
Mar 2017 — Present
Stability lead for biologics portfolio. Lead and develop team in support of product stability for drug substance and drug product biologics programs, supporting execution of stability studies across both Merck and external partner labs. Design studies to support product expiry and storage conditions, evaluate data trends, and author and review CMC Regulatory stability sections of global regulatory filings. Coauthor updated stability chapter of Quality Manual and participate in team to influence ICH Quality chapter revisions.
Education
The College of New Jersey
Bachelor of Science, Chemistry
1992 — 1996
Temple University
Masters of Science, Quality Assurance and Regulatory Affairs
2004
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