Manufacturing and QA professional with experience in the areas of pharmaceutical and food production. Experienced in cGMP regulatory compliance. Experienced in cell culture process scale up, from bench to industrial scale. Experienced in industrial biotechnology process equipment design and technical support. Additional experience in down stream separation and filtration of fermentation products. Experienced in the area of Cold Chain and Ambient Distribution Planning for finished goods. FDA Consent Decree experience as third-party oversight reviewer and approver of equipment qualification protocols and batch documentation. Recipient of the 2010 Merck Chairman's Award for Environmental Achievement.

Highlights:

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• Microbiological Testing
• Packaging
• Policies and Procedures
• Production Schedule
• SAP
• Supply Chain
• Support
• Technical Support
• Test
• Corrective Actions