Edwin Moore

Clinical Professor @Landuyt Center For Entrepreneurship

Mundelein, IL, US
EMAILS
e•••••@illinois.edu
MOBILE NUMBERS
+12•••••••95

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WORK HISTORY

Jul 2020 — Present

Clinical Professor @Landuyt Center For Entrepreneurship

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Champaign-Urbana, IL, US

EDUCATION

1972 — 1975

Cornell University

PhD, Physical Biochemistry

1968 — 1972

University of Illinois Urbana-Champaign

B.S., Biochemistry

SKILLS

Iso 13485ImmunologyAssay DevelopmentGlpMedical DevicesCapaImmunoassaysDrug DeliveryCROCommercializationPharmaceutical / Biopharmaceutical Product DevelopmentAseptic ProcessingOncologyClinical ChemistryChemistryRegulatory AffairsLifesciencesPurificationClinical Chemistry Diagnostic Method Development21 Cfr Part 11Design ControlVaccinesRegulatory SubmissionsProtein ChemistryPharmaceutical IndustrySopFdaValidationClinical DevelopmentLife SciencesChange ControlAnalytical ChemistryQuality SystemHplcProduct DevelopmentTechnology TransferBiotechnologyProtein PurificationDrug DevelopmentBiopharmaceuticals

ABOUT EDWIN MOORE

contact me: e••••••••@gmail.com Ed Moore brings 30 years of biopharmaceutical, pharmaceutical, and clinical diagnostic industry experience from global companies, Baxter Healthcare Corp and Abbott Laboratories, in R&D product development. During his career, he has held various roles in CMC pre-clinical product development for recombinant therapeutic proteins and for IV parenteral small molecule products in Analytical Method Development, Stability Testing, Formulation, as well as leading overall pre-clinical product development for a recombinant therapeutic protein product. He has held positions from bench scientist, R&D Product Development, to Sr. Director, Global Analytical Method Development and Validation. Ed’s responsibilities have included lead scientist for chemistry and protein biochemistry, subject matter expert in CMC pre-clinical product development, personnel management, budget responsibilities, managing outsourced work at CROs and project management. At Abbott Diagnostics, Ed managed R&D groups responsible for TDx therapeutic drug monitoring reagents, instrument, and software; for identifying and developing new biomarkers; and for new technologies that could be developed into new novel diagnostic systems. Ed has written CMC sections for regulatory filing for biologics and for small molecule products. Ed has also participated and presented to FDA and EMA regulatory bodies for scientific advice and product proposals. At Abbott Diagnostics, he collaborated with regulatory affairs groups to write 510(k) applications for medical diagnostic products.In addition to job responsibilities, Ed has been the industry chair for the WCBP conference which is co-sponsored by FDA and by Ed has also been a member of the AAPS National Biotech Conference, the AAPS Analytical Pharmaceutical Quality Section, and the AAPS Pharmaceutical Impurities Focus Group. SPECIALTIES: Biopharmaceutical, pharmaceutical, clinical diagnostic product development. CMC development and lifecycle management.

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