Kyle Leeman

Background

About Kyle Leeman

At my core, I am an executive and scientist in the biotechnology, pharmaceutical and CMC spaces that specializes in analytical R&D, QC, project management, and regulatory authoring. From preclinical stages to commercialization of small molecule drug substance and drug products, I am involved widely in analytical strategies and deliverables. Throughout my career, I have had the opportunity to stay connected to what I am most passionate about – the science – in a variety of ways, both in the lab and at the leadership level. No matter the capacity, I make it a priority to stay close to science via subgroups, development activities, regulatory authoring, and mentorship. Though I have become an executive technical leader, it was never something on my radar. The evolution happened naturally, and along the way I found that my scientific background lent itself well to understanding my team’s needs, daily obstacles, and how I can best empower. I will always be a scientist at heart, but I also find great purpose in being a leader and mentor. Key Areas of Expertise: • Deep experience in the design and execution of DS/DP analytical strategies. • Knowledge of varied analytical techniques, including HPLC, GC, MS, ICP-MS, FTIR, KF, PXRD, Dissolution, PSD, DSC/TGA. • Technical expert in the authoring, reviewing, and submission of phase-appropriate / fit- for-purpose regulatory documentation with distinct experience developing Module 3 regulatory section templates (IND/NDA). • Extensive regulatory interactions and strong knowledge of varying global guidelines. • Stage Gate process leader with critical understanding of the various phases of development and project lifecycles. • Proponent of continuous improvement with history supporting systems, equipment, and process initiatives to expand organizational capacity. • Effective and empathetic leader of 20+ person analytical labs.