Kevin Mc Cracken
About
Kevin Mc Cracken is from United States. Kevin is currently Head of Quality and Regulatory Affairs at BioFactura, Inc., located in Frederick, MD. In Kevin's previous role as a Senior Vice President of CMC at Équilibre BioPharmaceuticals Corp., Kevin worked in Pittsburgh, PA / New York City, NY until Aug 2023. Prior to joining Équilibre BioPharmaceuticals Corp., Kevin was a Chief Operating Officer at Noveome Biotherapeutics, Inc. and held the position of Chief Operating Officer at Greater Pittsburgh Region. Prior to that, Kevin was a Vice President of CMC at Kadmon Pharmaceuticals, based in Pittsburgh, PA / New York, NY from Aug 2011 to Oct 2019. Kevin started working as Senior Director of Quality at Kadmon Pharmaceuticals in Pittsburgh, PA in Jan 2008. From Mar 2007 to Jan 2008, Kevin was Director of Quality at Acambis, based in Rockville, MD. Prior to that, Kevin was a Senior Manager of Quality Assurance at MedImmune, based in Frederick, MD from Sep 2004 to Feb 2007. Kevin started working as QC Analyst > QC Manager at MedImmune in Gaithersburg, MD > Frederick, MD in Aug 1995.
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Kevin Mc Cracken's current jobs
Monoclonal Antibody and Recombinant Protein Therapeutics Establishment and maintenance of production facility compliance (QA/QC/RA) for the development of recombinant proteins and antibodies as critical medical countermeasures in treatment of infectious disease.
Kevin Mc Cracken's past jobs
Small Molecule Therapeutics Formulated solid oral dosage form and established manufacturing and clinical supply chains for the clinical development of therapy treating neurological disease.
Cell Therapy and Cell-derived Therapeutics Operational oversight of Quality, Manufacturing, Clinical, Regulatory and Project Management functions to achieve development of a novel cell/secretome therapeutic product in the treatment degenerative disease and wound healing.
Monoclonal Antibody and Small Molecule Therapeutics Pre-clinical to Commercial development of both monoclonal antibodies and new chemical entities for the treatment of solid tumor cancers, autoimmune and degenerative diseases.