Sam is a senior level scientist with 29 years of experience in product development, development strategy, outsourcing, contractor selection and management, CMC regulatory document preparation and CMC strategy. Strong technical skills include the ability to communicate technical information at all levels within an organization.

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.