
Paula Shadle, PhD
Strategic CMC and Quality Systems Expert
Career Highlights
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Principal consultant of Shadle Consulting Services, offering strategic CMC consulting and quality systems to biopharmaceutical and pharmaceutical firms seeking efficient and compliant quality systems throughout the product life cycle
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Helps virtual biopharma firms establish quality systems, develop and transfer CMC processes, and prepare and support international sites for US inspections
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Facilitates the work of multi-national teams and supports clients with international regulatory challenges
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Advises firms in Europe, Japan, the USA and Canada
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Co-inventor on five process patents
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Author of more than 30 publications
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Technical and senior management positions in protein chemistry, cell biology, process development, and QA/QC, at Chiron Corporation, Scios Inc., SmithKline Beecham Pharmaceuticals, Rhein Biotechnology and Bayer Corporation
Education
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Postdoctoral training: Fellow at the Max Planck Institute for Biophysical Chemistry
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BS and PhD, Biology: University of California
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Fluent in German