With 20+ years of biotech experience and 15+ in a process engineering role, I am passionate about mentoring others and leveraging my broad experience to solve the problem at hand. I am often recognized for keeping a cool head, whether I’m responding to urgent manufacturing process issues or presenting to FDA Inspectors.Here is what sets me apart:- I have been a primary subject matter expert for more than 20 health authority inspections by FDA, EMA and 6 other health authorities- I have exceptional breadth of manufacturing engineering experience: Clinical Phase I-III through commercialization, ongoing commercial production and tech transfer; bacterial fermentation, mammalian cell culture, and purification.- I have advanced technical writing skills and have frequently authored original content that has been adopted as a best practice template for others. The technical documents I have authored include characterization/validation protocols and reports, SOPs, batch records, and deviation evaluations.I am currently looking to expand my network and connect to former colleagues.