Experience

Pharmatech Associates, a USP company

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Principal Engineer

  • 2009 - Present

  Consulting at client sites on process troubleshooting, experimental design and execution, process validation strategy, solid dosage form coating, and aseptic process. Training on-site teams in statistically based experimental design, sampling methodology, and root cause analysis. Formulating statistically based acceptance criteria and sampling methods for process validation under 2011 FDA process validation guidance Consulting at client sites on process troubleshooting, experimental design and execution, process validation strategy, solid dosage form coating, and aseptic process. Training on-site teams in statistically based experimental design, sampling methodology, and root cause analysis. Formulating statistically based acceptance criteria and sampling methods for process validation under 2011 FDA process validation guidance



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director

  • Jan 2005 - May 2008

  Lead Validation and Process Engineering departments. Project Leader of commercial aseptic facility. Subject matter expert in aseptic and process validation. Lead Validation and Process Engineering departments. Project Leader of commercial aseptic facility. Subject matter expert in aseptic and process validation.



Aradigm Corporation

• Sr. Staff Process Engineer

  • 1999 - 2005

  Project leader for design and implementation of commercial form/fill/seal line. Project leader for compounding scale-up. AERx (inhaled insulin device) core team member. Subject matter expert on aseptic processing and design of experiments. Project leader for design and implementation of commercial form/fill/seal line. Project leader for compounding scale-up. AERx (inhaled insulin device) core team member. Subject matter expert on aseptic processing and design of experiments.



Collagen Corporation

• Manager, Engineering Services

  • 1991 - 1999

  Lead engineering department supporting commercial aseptic manufacturing process and equipment/process validation. Invented and built novel large-scale aseptic mixing equipment. Change control system administrator. Lead engineering department supporting commercial aseptic manufacturing process and equipment/process validation. Invented and built novel large-scale aseptic mixing equipment. Change control system administrator.