of people with debilitating diseases. Mr. Duguid is currently responsible for developing, validating, and transferring molecular biology assays for rapid microbiology and cell differentiation applications, managing complex projects to implement process changes, and using statistical process control tools to implement process analytical technology for cell therapy products. He has been at Genzyme since 1995.
Before taking on his current technical role, Mr. Duguid managed quality control cell therapy operations at Genzyme for over 10 years, where he designed and implemented a comprehensive cGMP-compliant raw material program controlling 300-400 parts and participated in 16 vendor audits, directing 4 as lead auditor. He also represented QC during 10 FDA inspections and numerous audits from international regulatory authorities as a subject matter expert in material inspection and release, biopsy accessioning, endotoxin testing, Mycoplasma testing, analytical methods, flow cytometry, laboratory failure investigations, assay validation, and data management.
Mr. Duguid received his Bachelor of Science degree in chemistry in 1986 from the University of Michigan in Ann Arbor, MI and taught analytical chemistry in 2000 at Northeastern University in Boston, MA. Prior to joining Genzyme, he worked in analytical research at Abbott Laboratories’ Pharmaceutical Products Division in North Chicago, IL and then as a scientific consultant for Massachusetts biotechnology companies at Arthur D. Little in Cambridge, MA. Involved with the pharmaceutical and biotechnology industries for over 20 years, Mr. Duguid has technical and management experience spanning all phases of the product lifecycle from early research and development through cGMP quality operations.