Anil K. Rattan, Ph.D.
About Anil K. Rattan, Ph.D.
Anil K. Rattan, Ph.D., is the Head of Quality Assurance (GMP and GCP, Senior Director) at Ocugen, where he has worked since 2023. He has extensive experience in quality assurance and compliance, having held senior roles at various pharmaceutical companies and conducted numerous regulatory inspections.
Work at Ocugen
Anil K. Rattan, Ph.D. currently serves as the Head of Quality Assurance (GMP and GCP, Senior Director) at Ocugen, a position he has held since 2023. Based in Malvern, Pennsylvania, he is responsible for overseeing quality assurance processes related to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). His role involves ensuring compliance with regulatory standards and conducting audits to maintain the integrity of clinical trials and manufacturing processes.
Previous Experience in Quality Assurance
Prior to joining Ocugen, Rattan held several significant positions in the field of quality assurance. He was the Director of CMC Quality at Immunovant from 2021 to 2022 and served as the Director of Global Quality Governance & Risk Management at Apellis Pharmaceuticals from 2019 to 2021. His experience also includes roles at Boston Biomedical, Shire Pharmaceuticals, and Cyteir Therapeutics, where he focused on quality auditing, compliance, and governance across various regulatory frameworks.
Educational Background
Anil K. Rattan earned his Doctor of Philosophy (Ph.D.) in Biology, specializing in Animal Neurosciences, from Guru Nanak Dev University from 1984 to 1988. He also obtained a Master of Philosophy (M.Phil.) in Biology with a specialization in Neuroscience from the same institution between 1982 and 1984. His educational background provides a strong foundation for his expertise in quality assurance and compliance within the pharmaceutical industry.
Regulatory Inspection Experience
Rattan has extensive experience in conducting and participating in regulatory inspections for various international regulatory bodies, including the FDA, EMA, MHRA, HPRA, HC, and TGA. His involvement spans both clinical and manufacturing sectors, where he has led inspection readiness activities and guided organizations through the regulatory process to ensure compliance with industry standards.
Quality Management Initiatives
Throughout his career, Rattan has developed and executed quality plans aimed at ensuring compliance with Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP). He has established Key Performance Indicators (KPIs) to monitor quality performance across organizations, enhancing transparency and accountability in quality management. His leadership in quality assurance has contributed to the successful filing of Biologics License Applications (BLA) and the readiness for regulatory inspections.