Amanda Miller
Director Analytical Testing, External Operations
- Role
- Director Analytical Testing, External Manufacturing at Vir Biotechnology, Inc.
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Amanda Miller
Knowledge of global CMC regulations and guidelines• Prepare, author, and maintain global regulatory dossiers• Proven leadership skills in both analytical science and formulation development• Experience with antibody and other therapeutic protein modalities• Mastery of analytical and biological chemistry techniques
Experience
Director Analytical Testing, External Manufacturing
Oct 2022 — Present
Manage contract testing laboratories (CTLs) and analytical testing delivery for Vir’s portfolio, including planning, performance management, compliance, and logistics support• Integration of testing activities into overall production plan and program timeline• Develop site selection criteria and engage with External Manufacturing Leads to integrate analytical requirements into CDMO selection• Contribute to strategic direction for analytical testing and manufacturing to create a competitive advantage
Education
University of Washington
Bachelor of Science (B.S.), Biochemistry
1999 — 2003
Skills
- Monoclonal Antibodies
- Assay Development
- Drug Discovery
- Cell Culture
- Design Thinking
- Regulatory Submissions
- Chromatography
- Hplc
- Pharmaceutical Process Development
- Technology Transfer
- Antimicrobial Resistance
- Life Sciences
- Antibody-Drug Conjugates
- Biotechnology
- Protein Purification
- Technical Writing
- Tissue Culture
- Analytical Methods Development
- Laboratory
- Mass Spectrometry
- Biopharmaceuticals
- Biochemistry
- Protein Chemistry
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