Pharmaceutical Dosage Form Process Engineer: Spray Congealing, Spray Drying, Fluid Bed Coating and Fluid Bed Granulation

Expertise

• 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:

• Granulation
• Compression
• Extrusion (melt extrusion and continuous granulation)
• Spray congealing
• Spray drying
• Fluid bed coating
• Fluid bed granulation
• Nanoparticle processing
• Solid dispersions
• Osmotic dosage forms

Experience

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)

Credentials

• Professional Engineer registered in the State of Oregon

Publications

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

Patents

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

Education

• B.S. Chemical Engineering, Montana State University, Bozeman, MT