Dorie is experienced in formulation, process development, scale-up, and technology transfer in the Pharmaceutical industry.

She has nearly 30 years in the Pharmaceutical sector, her expertise is in solid dosage formulation and process development from pre‐clinical through marketing application. Her development experience has included compressed tablets using roller compaction, wet granulation (continuous, high shear, and fluid bed) melt granulation and direct compression processing, hot and low melt extrusion, aqueous tablet coating and filling of hard gelatin capsules.

Dorie has facilitated and conducted GEMBAs of pharmaceutical products at numerous global manufacturing sites and assessed them for process robustness to identify areas for increased product yield and quality. She designed and implemented projects and experiments for process improvements to enhance overall product quality and yield.

A technical leader with over 22 years experience in formulation and process development of multiple NCE’s and line extension products coordinating drug product formulation, manufacturing process and development, scale-up and transfer to global manufacturing sites.

She has contributed to several cross-functional initiatives (market image branding, technical risk assessments, control strategy, and process validation exercises) of multiple oral solid dose products.

Dorie lives in Bullock NC USA with her husband and family dogs.

Examples of projects completed:

  • Designed and executed experiments for an alternative technology project using a challenging low melt extrusion process. This work led to demonstration of feasibility in delivering a product with similar appearance and dissolution profile to the commercial product and endorsement to continue development.
  • Optimized capsule formulation and roller compaction process of an inherited high profile product within a short amount of time, keeping the clinical timings on track and leading to a more robust and commercializable drug product formulation.
  • Coordinated the development and manufacture of Phase III supplies, which included overcoming multiple obstacles that presented themselves for a late stage in-license and troubleshooting and resolving a number of issues during the actual manufacturing campaigns. This had a direct impact of keeping the program on track.
  • Led and developed the process capabilities of a continuous granulation process for a high profile GSK product, delivering formulation and Phase 2 clinical supplies using future first intent technology.
  • Supported the tech transfer to manufacturing site, which resulted in a timely submission of the NDA and ensured the security of supply for a very critical medicine.