Khaled Aamer, PhD, is the Founder and Principal Consultant of XGene Consulting, where he supports pharmaceutical and biotechnology organizations with FDA regulatory CMC strategy, GMP remediation, inspection readiness, data integrity, quality-system improvement, and CMC Module 3 development. His work connects scientific evidence, regulatory expectations, and operational execution across development, manufacturing, submission, and remediation programs.
His prior experience includes serving as Senior Director and Head of Chemistry at GenapSys, Senior Principal Scientist and CMC Team Leader at Pfizer, Senior Scientist CMC Consultant at Generation Bio, Senior Manager at Pall Corporation within Danaher, and Senior Associate at Lachman Consultants. His technical foundation also includes polymer science research and subject-matter experience associated with NIST. He holds a PhD and MS in Polymer Science and Engineering from the University of Massachusetts Amherst, as well as graduate and undergraduate degrees in chemistry.
His published XGene work addresses FDA inspection-response strategy, OOS and CAPA investigation quality, ALCOA+ data-integrity remediation, science-based Module 3 and Quality Overall Summary development, and the transition toward structured, reusable, and AI-ready CMC knowledge.