KC

Kevin Mc Cracken

Quality and CMC Executive
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Email: ****@****.***
LinkedIn: Kevin McCracken
Location: United States
Current employer:
BioFactura, Inc.
Current title:
Head of Quality and Regulatory Affairs
Last updated: 29/05/2026 12:51 PM
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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.

Kevin Mc Cracken can be found on Finalscout.com, where members can access Kevin Mc Cracken's email for free. Finalscout is a professional database with more than 500 million business professional profiles and 200 million company profiles.

Kevin Mc Cracken's current jobs
Company: BioFactura, Inc.
Title: Head of Quality and Regulatory Affairs
Period: Sep 2023 - Present (2 years, 9 months)
Location: Frederick, MD

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
Company: Équilibre BioPharmaceuticals Corp.
Title: Senior Vice President of CMC
Period: Jul 2022 - Aug 2023 (1 year, 1 month)
Location: Pittsburgh, PA / New York City, NY

Small Molecule Therapeutics Formulated solid oral dosage form and established manufacturing and clinical supply chains for the clinical development of therapy treating neurological disease.

Company: Noveome Biotherapeutics, Inc.
Title: Chief Operating Officer
Period: Oct 2019 - Aug 2022 (2 years, 10 months)
Location: Greater Pittsburgh Region

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.

Title: Vice President of CMC
Period: Aug 2011 - Oct 2019 (8 years, 2 months)
Location: Pittsburgh, PA / New York, NY

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.

Title: Senior Director of Quality
Period: Jan 2008 - Jul 2011 (3 years, 6 months)
Location: Pittsburgh, PA
Company: Acambis
Title: Director of Quality
Period: Mar 2007 - Jan 2008 (10 months)
Location: Rockville, MD
Company: MedImmune
Title: Senior Manager of Quality Assurance
Period: Sep 2004 - Feb 2007 (2 years, 5 months)
Location: Frederick, MD
Company: MedImmune
Title: QC Analyst > QC Manager
Period: Aug 1995 - Sep 2004 (9 years, 1 month)
Location: Gaithersburg, MD > Frederick, MD
Kevin Mc Cracken's education
University of Pittsburgh
Bachelor of Science (BS)
1990 - 1995
Frostburg State University
Master of Business Administration (M.B.A.)
2001 - 2003
Kevin Mc Cracken's top skills
Clinical Development Regulatory Strategy Development GMP Commercial and Clinical Supply Chain Aseptic Processing CMO management FDA Production Management Manufacturing Management (on-site and CMO) Clinical Product Development Staff Development Solid Dose Formulation Clinical Drug Supply Biopharmaceuticals Clinical Operations Facility Design and Compliance Quality Process Development Manufacturing Processes Biotechnology CAPA
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