Sam is experienced in all aspects of oral solid dosage manufacturing including high-shear and fluid bed granulation, roller compaction, tumble blending, soft gelatin encapsulation, tablets, encapsulation, Wurster coating, and spray casting of functional and non-functional polymers for tablet/pellet coating. Significant experience developing novel formulation and process approaches to stabilize, increase solubility and increase bioavailability active pharmaceutical ingredients in drug products. Additional experience developing combination products.
Sam has a M.S. in physical chemistry from North Carolina State University and a B.S. in chemistry from Grove City College.
Sam currently resides in Raleigh, North Carolina USA.
Examples of projects completed:
- Project work resulted in the successful registration and launch of four drug products.
- Successful registration and launch of one combination product.
- Provided early product development support for two molecules leading to successful IND filings in the last two years.
- Directed scale-up and technology transfer activities from development sites to sites of commercial manufacturing.
- Write and review all aspects of technical terms of supply agreements with external contractors for tech transfer and clinical/registration batch manufacture.
- Provide due diligence reviews and selection of commercial manufacturing partners for clients.
- Introduced the use of chemical stabilizers, ionic gelation, non-solvent addition and differential thermal solubility coacervation as practical means of stabilizing active pharmaceutical ingredients.
- Provided analytical support activities such as raw materials testing, method development, release, in-process and stability testing for drug products.
- Provide CMC support for regulatory filing activities.
- Developed handling and containment strategies for Occupational Health Category compounds 4 and 5.
- Key member of the development team that guided the initial pilot plant construction and systems validation, including development of cGMP systems and SOP writing.