Providing technical solutions and regulatory strategy for the manufacture of biological pharmaceuticals defines my career. I have led analytical teams supporting a wide range of products that include recombinant proteins, pegylated proteins and oligonucleotides, antibody drug conjugates (ADC), glycosaminoglycans (heparin products), vaccines, enzymes, and blood products. Lifecycle management including producing and qualifying reference materials/critical reagents, troubleshooting analytical methods, and responding to regulatory queries is a large part of my role. Often my analytical team activities had high visibility, when a process observation and follow-up analytical characterization had impact on $42 million worth of product, or when a change in a laboratory consumable threatened continued manufacturing. I led an academic/industry/government team to solve a global problem during the heparin contamination crisis of 2007 with lifesaving impact. This accomplishment was recognized by the United States Pharmacopeia (USP) with the “USP Award for an Innovative Response to a Public Health Challenge”. I like working with talented people, they challenge me, teach me, and make me better. I have been told I provide the same value to my team members. Many industry improvements focus on efficiency requiring a blend of technical excellence, quality, and cost which makes my projects both challenging and enjoyable. I enjoy discussing scientific challenges and pharmaceutical quality with the public so they can make informed decisions regarding pharmaceutical products for their health. I use the same unassuming communication style in my other role as a scuba diving instructor when I work with students teaching them to stay safe while exploring the oceans. The pharmaceutical industry continues to innovate and evolve, especially with regard to novel biological product forms. I am fortunate to have a platform where I can contribute to this evolution.
