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

Technical Consultant #1622


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
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