Pharmaceutical Sciences, Animal Health R&D

Formulation Development - Enabling Technologies• Leader of Hot Melt Extrusion Technology Development Team: responsible for development of new technologies to support future project needs and contributing to overall solid dispersion strategy at Merck.• Responsible for formulation, process definition, and clinical manufacture to support first in man through phase IIB studies with an emphasis on solubilization technologies such as amorphous dispersions (hot melt, spray drying), nanotechnology, and microemulsions. • Defined two preliminary market formulations ensuring process robustness in a quality by design (QbD) paradigm and successfully transitioned them to commercialization.• Hands-on experience with set-up, processing, and trouble-shooting of most pharmaceutical unit operations.

Parenteral Delivery Team, R&D Planning & Intellectual Property Team• Unambiguously selected core technology for the in-house development of a sustained release formulation of G-CSF via thorough scientific evaluation of several candidate drug delivery systems.• Tested feasibility and successfully developed formulations based on in situ gelling hydrogels and polymeric nanoparticles for the delivery of protein and peptide therapeutics such as G-CSF and GLP-1 that met vital project criteria for release duration.• Managed preclinical safety and biocompatibility testing of a novel polymeric sustained release platform/medical device that was conducted at a US-based CRO under GLP conditions.• Discovered and evaluated potential project strategies for the establishment of a US-based subsidiary company through literature review, symposium attendance, and international networking with industrial, clinical and academic contacts.

• Robustly tested the feasibility of an oral GLP-1 formulation based on polymeric micelle and hydrogel technologies including in vitro testing of enzymatic degradation, stability, bioactivity, and controlled release profiles.• Recommended, established, and validated a Caco-2 cell system to screen multiple formulation variables and enhancers for increased permeability prior to in vivo studies resulting in a significant decrease in experimental time and expense.• Planned and analyzed in vivo studies in SD rats utilizing training in pharmacokinetic modeling and WinNonLin to efficiently compare formulation variables. • Actively maintained collaborations with parent company’s R&D center (Korea) and local US companies. • Responsible for oral and written presentations, human resource recruitment, preliminary market analysis, and budget management.