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Libby Russell, PhD.

Vice President & Senior Consultant

Libby brings over 20 years of experience in the bio/pharma industry with a focus on product and process development, commercialization and regulatory strategy.

Her work experiences in the biotech industry at Amgen, Inc. and Ophthotech had her leading product commercialization efforts overseeing analytical, tech transfer, validation, regulatory and process development activities. She has experience working on a range of products and modalities for both drug substance and drug product GMP manufacturing including monoclonal antibodies, oligomers, glyco-proteins and vaccines. At Amgen, she was the Process Team Leader for a commercial monoclonal antibody product, supporting manufacturing at two commercial facilities. During her time at Ophthotech, as the Associate Director of Commercial Manufacturing, she oversaw the oligo-based API and Drug Product contract manufacturing implementing Operational Excellence to improve productivity. Her additional responsibilities included: process validation support, regulatory document authoring, technology transfer documentation and commercial support.

She received her Ph.D. in Chemical Engineering from the University of Colorado-Boulder studying protein aggregation in cell culture. Libby has also worked with the university as a lecturer in the Chemical Engineering department.

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