Mark G. Epstein

About Mark G. Epstein

MS Organic Chemist, with extensive Analytical and Process Development experience in the areas of Oligonucleotides, Proteins and Small Molecules. SME level experience in analytical method development / validation / tech transfer to external CMO\'s & SOP writing under cGXP, USP, EP, JP & ICH guidelines. Technical support for multiple regulatory filings in US, EU & ROW

Experience

1. Oligonucleotide Therapeutics Consultant, Analytical Development & Quality Control

   Astellas Pharma

   Apr 2024 — Present

   Post acquisition support for IZERVAY™Providing AD & QC support for domestic commercial supply and foreign regulatory submissionsDossier Management Authoring responses to application deficiencies (RFI) from regulatory agencies Analytical Technological Transfer to multiple CRO’s/CMO’s worldwideQC data review for DS & DP manufacturing release and stability studies at CMO’sStability study data management and longitudinal trendingOOS investigations at CMO’s, Deviation and CAPA managementAnalytical method revision drafting, technical review and approval at CMO’sReport and protocol drafting to support stability studies and ROW regulatory submissionsAnalytical tech transfer and validation following cGMP and ICH guidelinesOligonucleotide Chromatography SME: troubleshooting at CRO’s/CMO’sCRO management

Education

• University of Portland

  Bachelor of Science (BS), Chemistry

  2006 — 2010

• Montana State University-Bozeman

  Master of Science (MS), Synthetic Organic Chemistry

  2010 — 2012

Skills

• Organic Synthesis
• Hplc-Ms
• Column Chromatography
• Analytical Chemistry
• Icp-Oes
• Ftir
• Lyophilization
• Maldi-Tof
• U.s. Food and Drug Administration (Fda)
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Chemistry
• Nmr
• Validation
• Hptlc
• Microsoft Office
• Nuclear Magnetic Resonance (Nmr)
• Uv/Vis
• Purification
• Gas Chromatography
• Laboratory
• Hplc
• Atr-Ftir
• Fluorescence Spectroscopy
• Distillation
• Research
• Ir Spectroscopy
• Lc-Ms
• Uv/Vis Spectroscopy
• Laboratory Skills
• Nmr Spectroscopy
• Organic Chemistry
• Synthetic Organic Chemistry
• Crystallization