Murat A.

Production Manager Cellular Products Qualified Person @Miltenyi Biotec

organizing CMOs for cellular products: transfer of procedures and SOPs, training, validation and audits• Development and optimization of work flows defining the process of manufacturing • Contact with regulatory authorities regarding manufacturing authorization. Participation in replying to deficiency letter by the authorities, both in-house and for customers.• Qualification, training and GMP auditing of external sites • Establishing of cell product logistics within clinical trials• Writing and management of task related SOPs• Management of cellular products manufacturing activities including product release. Visit participating trials centers: monitor current quality status of centers regarding cell manufacturing. Identify responsible personnel, facilities and equipment. Summarize necessary steps to be taken to start clinical trial.• Managing IMP related activities in clinical trials incl. appropriate GMP document management (eg. IMPD)• ln-house training and education regarding GMP requirements for cellular products. Support of QA and regulatory challenges in personalized medicine.• Strong continuous knowledge improvement of cellular therapies and regulatory requirements by attending appropriate conferences, seminars etc.• Support internal decision process on regulatory strategy, compilation of position papers, internal trainings in strong cooperation with clinical operation and regulatory affairs department• commenting on relevant draft guidance documents from national and European authorities• contacts to regulatory authorities & compilation of dossiers• contact person for marketing and sales regarding ATMP regulation in Germany and Europe• GMP, GCP, AMWHV, QA, CAPA, OOS, OOT, Qualification, Validation• act as QP for final ATMP-IMP batch release in CIT• closed system/automated/manual/open/aseptic manufacturing