James Andahazy
About James Andahazy
James Andahazy is the Director, Business Operations Lead at Bristol-Myers Squibb in Princeton, New Jersey, with extensive experience in clinical trial operations and biospecimen strategies.
Title
James Andahazy is currently the Director and Business Operations Lead at Bristol-Myers Squibb in Princeton, New Jersey.
Professional Experience
James Andahazy has held various positions at Bristol-Myers Squibb, including Director of Business Operations Lead, Associate Director of Procedural Document Lead from 2014 to 2017, and Principal Sample Strategy Analyst from 2012 to 2014. Before joining Bristol-Myers Squibb, he worked as a Product Manager at Partec North America, General Supervisor for Esoteric Testing at Clearstone Central Laboratories, and Laboratory Scientist at MDS Pharma Services. James began his career as an Associate Research Scientist at BMS and also has experience as a Clinical Research Assistant at ICON Clinical Research and Lab Support at Bristol Myers Squibb Co.
Education and Expertise
James Andahazy holds a Bachelor of Science in Comprehensive Science from Villanova University and a Master of Business and Science in Drug Discovery and Development from Rutgers University-New Brunswick. He has expertise in GxP/ICH regulations and guidance, specializing in biospecimen strategies, clinical trial operations, quality by design principles, and Lean Six SIGMA methodologies.
GxP/ICH Regulations and Guidance
James Andahazy has comprehensive expertise in GxP/ICH regulations and guidance. These regulations are critical for ensuring compliance in clinical trials and pharmaceutical development, ensuring that all processes meet stringent regulatory and scientific standards.
Biospecimen Strategies and Clinical Trial Operations
James Andahazy specializes in biospecimen strategies, focusing on the collection, processing, and management of biological samples for research and clinical trials. He also has a strong background in clinical trial operations, which includes planning, conducting, and managing clinical trials to ensure they meet regulatory and scientific standards.