Mary-Ellen Ash

About Mary-Ellen Ash

Strategic and proactive Analytical Scientist with over 14 years of experience in…

Experience

1. Sr Research Scientist i

   Gilead Sciences

   Jan 2022 — Present

   Served as analytical/CMC project lead supporting clinical phase for API and drug products development. Present analytical project updates to sub-team and CMC meetings. • Developed phase-appropriate specifications and control strategies per regulatory guidelines and company policy. • Supervised multiple analytical teams. Managed analytical activities internally and at contract labs for API and DP, including method development/optimization, validation, transfer, release, and stability. • Authored analytical content for IND/IMPD/NDAs, regulatory filings for other regions, and responses to questions by various regulatory agencies. • Contributed to project strategy for meeting the timeline to support phase-appropriate studies. • Planned and managed the execution of experiments to support development activities and project goals. Led laboratory investigations on lab events, OOS and OOT results. Authored reports to document and support the findings from the laboratory investigations. • Oversaw outsourced project-related analytical activities at multiple CxO companies to meet key project timelines and deliverables. • Serve as SME for several multi-component programs including Genvoya, Biktarvy and Descovy.

Skills

• U.s. Pharmacopeia (Usp)
• Formulations
• Genvoya
• Hplc
• Empower
• Research and Development (R&D)
• Quality Control
• Glp/Gmp
• Pharmaceutical Industry
• Standard Operating Procedure (Sop)
• Chromatography
• Analytical Chemistry
• Multi-Component/Active Method Development
• Dissolution
• Lims
• Biotechnology
• Data Analysis
• Uplc
• Uv/Vis Spectroscopy
• Gmp
• Technology Transfer
• Method Development
• Drug Development