- Pharmaceutical process and product development.
- Design and development of unusual and novel pharmaceutical processes and dosage forms.
- Extensive experience from initial process development to commercialization.
- Process evaluation - process design, develop, scale-up, robustness, troubleshooting.
- Mass Transport and unit operations.
Extensive experience in unit operations in pharmaceutical processing development to commercialization:
- Extrusion (melt extrusion and continuous granulation)
- Spray congealing
- Spray drying
- Fluid bed coating
- Fluid bed granulation
- Nanoparticle processing
- Solid dispersions
- Osmotic dosage forms
Undisclosed Company, Partner, Independent Consultant, 2007 - Present
- Lead - Manager in formulation and process development activities for pharmaceutical and medical device companies.
- Provide strategic advice and tactical assistance regarding formulation design, process development, scale up, technology transfer and troubleshooting.
- Technical oversight of manufacture for pharmaceutical formulations.
- Project subject matter: NCE development, amorphous dispersion feasibility, development and scale-up, CR assessment, formulation and development, process scale-up, transfer and troubleshooting.
- Identify appropriate CRO and CMOs and manage outsourced development programs.
Bend Research, Bend, OR, Process Development Team Leader, 2004 - 2007
- Led process development and technology transfer of various drug delivery technologies including nanoparticles, multiparticulates and solid dispersions.
- Responsible for transfer of multiple processes into GMP manufacturing facilities.
- As Technical Lead, served as process development expert for extrusion, fluid bed coating and spray congealing processes.
- Responsible for transfer of multiple processes into GMP manufacturing facilities including spray drying, fluid bed coating, hot melt extrusion, nano emulsification and nano precipitation.
- Served as process development expert for extrusion, fluid bed coating, spray drying and spray congealing processes. Led process development scale up and process tech transfer of Zmax, a sustained release microsphere product, from initial bench scale process to the commercial scale. Designed equipment for spray drying, spray congealing, and extrusion processes.
Honors & Publications
Academic and Professional Affiliations
- American Association of Pharmaceutical Scientists (AAPS)
- American Chemical Society
- American Institute of Chemical Engineers (AIChE)
- Professional Engineer registered in the State of Oregon
Author and Co-Author: Of numerous presentations and publications with subject matters:
- Understand Fluid-Bed Coating
- Process Design, Development; Novel Pharmaceutical Dosage Forms
- Fluid-Bed Coating through Detailed Modeling
- Process - Formulation Strategies; Extrusion Applications
- Design Space Approach; Processing, Troubleshooting, Optimization - Fluid Bed Granulation Process
- Process - Formulation Approaches; Pharmaceutical Extrusion Applications
Participant in the following subject matters:
- Multiparticulates Comprising Low-Solubility
- Multiparticulates of Spray-Coated Drug and Polymer
- Extrusion Process - Forming
- Multiparticulate Compositions With Improved Stability
- Manufacturing Partially Cross-Linked Alginate
- B.S. Chemical Engineering, Montana State University, Bozeman, MT