Career Evolution & Innovation in Biomanufacturing
Meet the Panelists
Janelle Stoops, Director of Cell Therapy Process at Sonoma Biotherapeutics
Janelle Stoops is the head of the Process Development organization at Sonoma Biotherapeutics, leading the CMC sub-team function for our clinical pipeline. She graduated from Seattle Pacific University with a degree in Biochemistry. She has had the fortunate opportunity to work across the cell therapy and large molecule therapeutic industry at Sonoma Biotherapeutics, Juno/Celgene/BMS, and Amgen for the past two decades gaining critical skills and expanding her network. Her career has advanced from being a technical contributor at the bench to mapping out strategy while leading teams across process development, analytical development and early phase CMC teams. Janelle is a scientist by heart, leaning into data to guide decision making and working across multiple functions in shaping the innovation required for the cell therapy pillar.
Nathan Blazei, Senior Director Strategic Solutions at Kymanox
Nathan is the Senior Director of Strategic Solutions at Kymanox. He has over two decades of experience in the life sciences across pharmaceuticals, biotechnology, medical devices, and combination products. With a foundation in process development, manufacturing, quality, and regulatory compliance, he has a passion for ensuring problems are addressed in a manner that is technically sound but also of high quality and compliant with current regulations.
In his current role, Nathan bridges the gap between complex challenges in the life science ecosystem and innovative solutions that are within the Kymanox service portfolio. With a focus on customer satisfaction, he strives to accelerate the development of new therapies to improve health and well-being… because patients deserve better.
Nathan is a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ) and holds a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society (RAPS). He is currently a Board Member for the Parenteral Drug Association (PDA), Southeast Chapter. Nathan has presented at domestic and international industry events on various topics relevant to the life sciences, and he continues to offer training internally and externally to share best practices, lessons learned, and new approaches to old problems.
Dave Sehgal, Vice President of Global Process Engineering at CSL
Dave Sehgal, Ph.D., currently serves as the Vice President, Global Process Engineering for CSL Behring. In this role, Dave leads a team of over 500 scientists and engineers across four sites worldwide in the technical support of all CSL Behring products. Prior to this position, Dave worked for three years as the Site Head for the Seqirus Flu Cell Culture Facility in Holly Springs, NC where he was responsible for the production and supply of Seqirus’ manufactured products (influenza vaccines). Dave has more than 30 years of industry experience in biotechnology and pharmaceuticals and has worked in a variety of roles within the industry including: Vice President, Process Development at FUJIFILM Diosynth Biotechnologies, Senior Director, Quality Operations at Seqirus, and Director, Drug Product Operations, at Novartis (predecessor to Seqirus). Dave began his career at Merck & Co., after earning his Bachelor of Science degree in chemical engineering from NC State University. During his 18 years at Merck, Dave worked in various roles within technical services and operations management, and he earned both a master’s and doctorate degree in Chemical Engineering from NC State University through Merck & Co. sponsorship.