Personal Information
Organização/Local de trabalho
San Francisco Bay Area United States
Cargo
Analytical Development and Quality Control / Biologics / Group Manager / Bayer
Setor
Medical / Health Care / Pharmaceuticals
Sobre
Group manager with 15 years’ post-graduate biological research and development experience, including 10 years in CMC Analytical Development (AD) and clinical product Quality Control (QC).
Recently started a new leadership role in commercial product QC organization.
Technical skills in GMP release assay development, validation, comparability and transfer, as well as product extended characterization, GMP testing, CMC regulatory filing, etc.
Extensive project management and people management experience.
Specialized in separation science and physicochemical analysis. Broad experience in other areas of ADQC.
Experience with recombinant proteins, monoclonal antibodies, protein-polymer...
Marcadores
presentation
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Apresentações
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Tim Sandle, Ph.D.
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Tim Sandle, Ph.D.
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Tim Sandle, Ph.D.
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Stephan O. Krause, PhD
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MABs Stability – Analytical Techniques
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The Chemistry of Monoclonal Antibodies
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stability tests for pharmaceutical products
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Personal Information
Organização/Local de trabalho
San Francisco Bay Area United States
Cargo
Analytical Development and Quality Control / Biologics / Group Manager / Bayer
Setor
Medical / Health Care / Pharmaceuticals
Sobre
Group manager with 15 years’ post-graduate biological research and development experience, including 10 years in CMC Analytical Development (AD) and clinical product Quality Control (QC).
Recently started a new leadership role in commercial product QC organization.
Technical skills in GMP release assay development, validation, comparability and transfer, as well as product extended characterization, GMP testing, CMC regulatory filing, etc.
Extensive project management and people management experience.
Specialized in separation science and physicochemical analysis. Broad experience in other areas of ADQC.
Experience with recombinant proteins, monoclonal antibodies, protein-polymer...
Marcadores
presentation
Ver mais