Dan Mamelak, PhD,Founder and Director
From the outset of his career, Dan recognized the need for strong bioanalytical expertise to support the drug discovery programs of both developing and established biopharmaceutical companies. As Director of Custom Biologics™ he is responsible for the strategic direction of our company, and as a protein biochemist he oversees our bioassay and biologics science.
Prior to founding Custom Biologics™, Dan was a Senior Scientist at Affinium Pharmaceuticals, a company that accelerates the development of small molecules for new medicines. Here he developed high throughput platforms for the purification and mass spectrometry analysis of proteins, and supervised the development and management of a state-of-the-art cell culture facility. Dan is listed on patents stemming from his work at Affinium Pharmaceuticals. In addition, he has published in such leading scientific journals as the Journal of Biological Chemistry, the journal Biochemistry, and the journal Virology.
Dan holds a MSc in Microbiology from the University of Guelph and a PhD in Biochemistry from the University of Toronto.
Mary Mazur, PhD, Manager, Quality Assurance
Mary is the Manager of our independent Quality Assurance unit, bringing to the company 20 valuable years of experience in the areas of biologics and biopharmaceutics.
Mary has held senior level positions in quality assurance and regulatory affairs at Sanofi Pasteur, GlaxoSmithKline, Novartis, and most recently at the Biovail Corporation as the Corporate Vice President of Quality. Mary is also a founder and senior partner in the consulting firm IQC, which specializes in quality and regulatory operations. She has extensive experience with sterile manufacturing and cell culture scale-up, technology transfer and research, and development streamlining of GLP/GCP and GMP. She has been a team leader for numerous pre-approval inspections from the USDA, Health Canada, and the Medicines Control Agency/European Medicines Agency, all of which have resulted in successful drug approvals.
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"We chose to work with Custom Biologics™ because we needed someone who would understand our innovative and novel approach." – J. W., PhD, Manager, Non-Clinical Discovery