Paul Jedrzejewski
About Paul Jedrzejewski
Paul Jedrzejewski serves as the Executive Director of Analytical Development, Quality Control, and Bioanalytical at Aimmune Therapeutics, where he has worked since 2020. He possesses extensive experience in method development, regulatory submissions, and assay development across various pharmaceutical companies.
Current Role at Aimmune Therapeutics
Paul Jedrzejewski currently serves as the Executive Director of Analytical Development, Quality Control, & Bioanalytical at Aimmune Therapeutics. He has held this position since 2020 in Brisbane, California. In this role, he oversees various aspects of analytical development and quality control, ensuring compliance with industry standards and regulatory requirements.
Previous Experience at Aimmune Therapeutics
Prior to his current role, Paul Jedrzejewski worked at Aimmune Therapeutics as a Senior Director of Analytical Development and Quality Control from 2018 to 2020. He also served as a Consultant for the company from 2017 to 2018. His tenure at Aimmune Therapeutics has contributed to his extensive expertise in the field.
Professional Background in Pharmaceutical Industry
Paul Jedrzejewski has a diverse background in the pharmaceutical industry, having held various positions at notable companies. He worked as a Senior Scientist at Genencor International from 2001 to 2004, and as a Principal Scientist at Chiron Corporation and Novartis from 2005 to 2007. He also served as Principal Scientist at Amylin Pharmaceuticals from 2007 to 2012 and as Associate Director at BioMarin Pharmaceutical Inc. from 2013 to 2014.
Education and Expertise
Paul Jedrzejewski holds a Ph.D. from Virginia Tech and a BS in Chemistry from The George Washington University. His educational background supports his specialization in method development and validation for various therapeutic modalities, including small molecules, proteins, and peptides. He has extensive experience in assay development and regulatory submission management.
Skills in Analytical Development and Quality Control
Paul Jedrzejewski specializes in coordinating analytical testing and analysis services for research and GMP testing. He has a strong background in assay development techniques, including chromatographic, spectroscopic, and mass spectrometric assays. His expertise extends to conducting drug substance and drug product comparability studies and resolving out-of-specification issues.