Elise Bradley

About Elise Bradley

A pharmaceutical drug development leader with 25+ years of experience in the pharmaceutical and biotech industry, I possess a strong technical foundation with in-depth CMC knowledge across all phases of development, from pre-clinical to commercialization and lifecycle management, and a proven track record of leading cross-functional teams to deliver late-stage assets.I have built and led highly skilled and flexible scientific teams, designed and implemented complex analytical and control strategies, and applied a range of techniques to ensure quality, safety, and efficacy. Additionally, I have successfully selected and managed CMOs and CROs nationally and internationally, authored and reviewed CMC sections for numerous regulatory filings (INDs, IMPDs, NDAs, MAAs), and interacted with the FDA as a subject matter expert. I am passionate about developing innovative and effective therapies for patients and advancing the scientific knowledge in the field.Specialties: • CMC regulatory filings authoring (IND, IMPD, NDA, MAA)• CMC due diligence, gap analysis, vendor selection, PAI readiness• Specification setting, stage-appropriate control strategy for drug substance and drug product• Impurity characterization and control; reference standard program• Stability program, shelf life and expiry dating, statistical trending• Phase-appropriate analytical method development and qualification / validation• Out-of-specification (OOS) investigations, method troubleshooting• Technology transfer, bridging studies• Dissolution methods• Technical reports• DS: small molecule and oligonucleotide; DP: solid oral dosage, parenteral

Experience

1. Executive Director, Cmc, Analytical Development

   Xenon Pharmaceuticals Inc.

   Jan 2025 — Present

Education

• ESPCI Paris - PSL

  Master’s Degree, Chemistry

• Pierre and Marie Curie University

  DEA (Diploma of Advanced Studies), Analytical Chemistry

Skills

• U.s. Food and Drug Administration (Fda)
• Glp
• Analytical Methods Development
• Analytical Chemistry
• Stability Programs
• Good Laboratory Practice (Glp)
• Drug Discovery
• Regulatory Requirements
• Ind
• Maa
• Leadership
• Regulatory Filings
• Pharmaceutical Industry
• Life Sciences
• Validation
• Regulatory Affairs
• Chromatography
• Nda
• Gas Chromatography
• Drug Development
• Biopharmaceuticals
• Dissolution Testing
• Biotechnology
• Research and Development (R&D)
• Cmc
• High-Performance Liquid Chromatography (Hplc)
• CMO Management
• Gmp
• Product Development
• Technology Transfer
• Standard Operating Procedure (Sop)
• Analytical Method Validation