Mark Stow has over 20 years of expertise in quality control, quality assurance, regulatory affairs, manufacturing, and business development supporting pharmaceuticals, biologics and cell and gene therapy products. He has worked with Teva Pharmaceuticals, Fraunhofer USA, Cognate Bioservices and Beckman Coulter in the U.S. and with AstraZeneca in the UK.
Mark is fully conversant with current EU and FDA GMP regulations. He has extensive experience in auditing and supporting quality systems.
His areas of recognized expertise include:
- Regulatory compliance
- QC laboratory design and start-up
- Analytical testing
- Facility design and validation
- Aseptic fill-finish operations