Prathyusha Guttikonda is a seasoned leader in pharmaceutical quality assurance with over 14 years of expertise spanning cell and viral therapy operations from clinical development to commercialization. She currently serves as Associate Director of Quality Assurance Operations at Lonza, where she leads quality strategy across manufacturing and supply chain operations for large-scale allogeneic programs. In her role, she provides strategic guidance to cross-functional teams, manages regulatory compliance with global standards such as the FDA and EMA, and ensures readiness for clinical and commercial launches.
Prathyusha’s career includes progressive leadership positions at Lonza, where she has directed QA operations teams, overseen batch release, and spearheaded initiatives to strengthen “right-first-time” execution in manufacturing. She has led the seamless transition of autologous and allogeneic cell therapies from early-phase clinical manufacturing to commercial launch, ensuring regulatory alignment and operational scalability. She has also contributed to greenfield site onboarding, including commissioning, facility qualification, risk assessments, and regulatory submissions, bringing strong technical expertise in aseptic processing and compliance frameworks. Earlier in her career, she held roles in quality control and analytical method validations, leading audits, ISO certifications, and method development for pharmaceutical products.
Her academic background combines scientific depth and business acumen. She holds an MBA from Rice University, a Master of Science in Chemistry from Eastern Michigan University, and a Master of Science in Pharmaceutical Technology alongside a Bachelor of Pharmacy from Jawaharlal Nehru Technological University in India. With this blend of technical expertise, leadership experience, and global perspective, Prathyusha is recognized for fostering a culture of compliance, ownership, and continuous improvement in highly regulated environments.