Kirk’s expertise lies in pharmaceutical analytical chemistry. He has a track record of global project and organizational leadership in R&D, delivered during the course of a 30-year career at GSK. He has broad experience with a focus on Stability; Method Development, Validation and Transfer; and Laboratory management and Quality.
Kirk received a BS degree in Chemistry from the University of Richmond and an MS degree from North Carolina State University. He began his career as a bench chemist supporting product development. He was quickly given the opportunity to lead analytical and pharmaceutical development teams that resulted in NDA approvals. These successes led to responsibilities of increasing scope and complexity resulting in Director-level roles for 15 years. He has led groups responsible for facility support, high throughput analytical testing, and topical product development of OTC and cosmetic products. While leading these technical groups he continued to make individual contributions and lead technical and business teams.
Kirk lives in Cary, NC, USA.
Examples of projects completed:
- Established a high throughput analytical testing laboratory with a staff of 50 chemists responsible for pharmaceutical late-stage stability testing of solid dose, liquid and inhaled products: work included recruiting and staffing, laboratory set up, tech transfer and capacity planning. Increased productivity of group by 50% by defining key performance indicators and using process improvement tools.
- Stability SME: Authored a suite of standard operating procedures and guidance and provided training while serving as R&D subject matter expert on Stability. Authored 19 expiry memos for skin health products under very tight timelines to meet ANVISA requirements to keep the products on the market. Developed a strategy and tool for evaluating product temperature excursions using Mean Kinetic Temperature.
- Regulatory and Quality: Led the preparation for regulatory inspections by the Swedish authorities resulting in approval to release clinical trial materials for Europe. Led the Analytical Quality Focus Network which required quarterly analysis and reporting of global analytical deviation data and managed the site OOS annual report process.
- Project leader for successful implementation of a global LIMS system: work included development and validation of templates, development and implementation of training materials, and change management.
- Project leader for the successful relocation of a large laboratory group and stability chambers from an R&D to a Manufacturing site; work included risk reviews and risk management, process optimization, regulatory inspection preparation and change management.
- Developed successful facility support groups at 2 sites at the time of a corporate merger. Group was responsible for cleaning verification, raw material testing, and comparator development.