SUMMARY OF QUALIFICATIONS Experience in the food and pharmaceutical industry in R & D, QA/QC, and technical services. Experience at the US Pharmacopeia developing standards for quality, identity, purity of small and large molecules. Experience in drugs, biotech derived products, medical devices and biocompatibility. Experience in troubleshooting in plants for microbiological environmental issues. Management of Laboratories with manpower of 120+. Management of Volunteers Expert Committees. * Expert in microbiological issues, testing, sterilization, troubleshooting in plants Expertise in the quality of animal and plant derived products chemical drugs as well as biotechnology derived products, including gene and cell therapy Strategic planning of R & D and QA, in program planning, and especially in project management * Establishment of internal bridges between R & D and the other functions of the enterprise. Established bridges with national & international organizations * Establishment of liaison with external stakeholders in academia, government, and industry. * Patent expert witness Close collaboration with FDA in setting quality standards for the US Pharmacopeia. Regulatory remediation

Highlights:

• Management
• Project Management
• Risk Management
• Biotechnology
• Bridges
• Developing Standards
• Environmental Issues
• Government
• Medical
• Medical Devices