Seasoned CMC Expert
30+ years of experience in Drug Development, Formulation Development, and Quality Assurance. Cross-functional leadership expertise spans strategic planning, change management, risk management, product strategy, and organizational effectiveness. Demonstrated excellence in managing departments of ~20 R&D personnel. Proven track record in the development, scale-up, and technology transfer for commercialization of drug products.
- Drug Delivery
- Small Molecules
Relevant Therapeutic Areas
- Allergy & Immunology
- Infectious Diseases
- Director, Global Formulations Development
- Associate Director, Process Development
- Greater Chicago Area
- Open to remote and in-office
- Small Biotechs
Skills & Accomplishments
- Executed numerous formulation development programs ranging from FIH to commercial launch.
- Designed, implemented, and maintained the Quality by Design program for both formulation and analytical sciences. Responsibilities included directing the global core quality by design implementation team, advancing risk assessment tools, training, and implementing quality by design principles for numerous projects.
- Successfully filed and gained approval for QbD submissions. Filings included sections covering, Quality Target Product Profile, Risk Assessments, Design Space, and Product Control Strategy.