| Mr. Eylath is a seasoned Quality Leader who is experienced in the complete life cycle of Small Molecule and Biological drug development: from discovery, through nonclinical and Tox studies, clinical trials, process and method development, GMP manufacturing, validation, regulatory submissions and US/EU/MHRA commercial product approvals. He has direct experience with process development, validation and QA/QC oversight for Cell Therapies and for therapeutic Monoclonal Antibodies and has led or supported cross-functional Continuous Improvement and Gap Remediation initiatives and projects. Mr. Eylath is an international thought-leader on Phase-Appropriate application of GMP to drug development and manufacturing and has presented seminars and training at PDA and ISPE events, as well as presenting on sterilization technology to CBER/CDER. He holds a lean-Six Sigma Black Belt (Amgen) and is Past President of the New England PDA chapter. |
