Scholarship and Biography
Ergun is a PhD Scientist specializing in analytical development, with a focus on method qualification, technology transfer, and regulatory support for cell and gene therapy programs. He has extensive experience working across early- and late-phase development in cGMP environments, supporting the advancement of complex biologic products.
He leads analytical method qualification and transfer activities for mRNA-based and cell and gene therapy platforms, working closely with Quality Control, Quality Assurance, and external partners to ensure compliance with regulatory expectations and robust quality systems. He has supported over 30 analytical method qualifications and transfers and contributes to analytical lifecycle strategies and team mentorship.
Ergun holds a PhD in Biochemical and Chemical Engineering. His research background includes viral vector systems and phage therapy, integrating engineering principles with biological systems to support a structured, risk-based approach to therapeutic development.
In addition to his industry experience, Ergun is an adjunct instructor at Brandeis University, where he teaches advanced topics in immunotherapy and regulatory science. His teaching emphasizes the connection between scientific innovation and real-world application, preparing students to navigate the scientific, technical, and regulatory challenges of the biotechnology industry.