Michael Knous

Background

About Michael Knous

As a Senior Manager of Statistics and Data Systems, I lead the nonclinical statistics program for all cell therapy products from early development to post-approval commitments. I am also responsible for designing and implementing process analytics solutions that improve the robustness, consistency, yield, and scalability of manufacturing processes. With over 10 years of experience in the biotechnology and food industries, I have a proven track record of success in delivering data-driven solutions that comply with regulatory requirements and support business objectives. My core competencies include statistical analysis, machine learning, data mining, data visualization, and regulatory compliance. I hold certifications in Six Sigma Black Belt, Quality Engineer, and Quality Auditor from ASQ. I am passionate about applying my statistical and data science skills to solve complex problems and generate insights that enable innovation and quality improvement. I enjoy collaborating with cross-functional teams and stakeholders to ensure alignment and integration of data and analytics across the organization. My goal is to leverage my expertise and leadership to advance the science and technology of cell therapy and make a positive impact on patients' lives.