David Achila, PhD, CQA is an Associate Director of Quality Control in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Achila manages the Quality control Unit of the Marcus Center for Cellular Cures (MC3). Dr. Achila is responsible for phase-appropriate in-process and final product testing and release to support clinical studies and regulatory filling. He is also providing QC support for regulatory and safety inspections, and leads QC non-conformance investigations, QC method development, validations and method transfers.
Dr. Achila received his Master of Science degree in Chemistry from Western Michigan University and subsequently earned his PhD in Biochemistry and Molecular Biology from Michigan State University. His research outcomes yielded insights in regulation of ribosomal assembly in B. Subtilis as well as immune evasion mechanism of Streptococcus pneumoniae. Upon graduation, Dr. Achila joined St. Jude Children Research Hospital in Memphis, Tennessee as a Postdoctoral Research Associate in the department of Infectious Diseases. Prior to his work at ORAQ, Dr. Achila held QC managerial positions at Cognate Bioservices (CMO) and Celgene (Now BMS) where he provided QC support to cell and gene therapy product development as well as GMP product and stability testing. Dr. Achila also supported the Operation WARP speed project on COVID vaccines as a QC Manager at Emergent BioSolutions. Dr. Achila is certified as Quality Auditor (CQA) and is member of leadership team in the Medical Device division of American Society of Quality (ASQ).