John Stults

My current role is Chair of the Analytical Review Committee in the Technical Development organization, with oversight of specifications for biologics in clinical development and at the time of commercial launch. Specifications are the analytical procedures and their acceptable ranges that ensure a safe and effective product. They are based on an understanding of each molecule’s attributes and their potential impact on activity, pharmacokinetics, immunogenicity, and safety – Critical Quality Attributes. My research interests include learning more about the biological impact of these attributes, for example, through in vitro and in vivo experiments to decipher how they change after administration to patients. I am also involved in continuing development of strategies for sequence variant analysis, comparability assessment, and control system justification.

In addition, my role provides many opportunities to guide and mentor scientists and team leaders.

• Michigan State University, PhD in Analytical Chemistry – 1985
• College of Wooster, BA in Chemistry – 1980

• Distinguished Contribution in Mass Spectrometry Award, American Society for Mass Spectrometry – 2002
• Analytical Chemistry Graduate Fellowship, American Chemical Society – 1983-1984
• Phi Beta Kappa, College of Wooster – 1980