Cmc Manager

Fondazione Telethon is one of Italy's leading charities.Since ****, on behalf of a community of patients, it has been working to fulfill the promise of curing rare genetic diseases by funding excellent biomedical research.We are looking for a CMC Manager to join our talented CMC Team.The successful candidate will be responsible for scientific integrity, regulatory compliance, and the execution of all Chemistry, Manufacturing & Control (CMC) activities for assigned cell and gene therapy programs throughout their lifecycle, including reporting for these programs.The CMC Manager oversees CDMO activities, has decision-making authority over CMC technical strategy and scientific recommendations and is responsible for escalating risks related to product quality, patient safety, regulatory compliance, or program timelines.RESPONSABILITY:Defining and implementing the CMC and Quality by Design (QbD) strategy for assigned programsSupporting CMC regulatory activities and dossier preparation (IND, IMPD, BLA, MAA)Manage control strategy, stability, and comparability, assessing the regulatory impact of manufacturing and analytical changesOversee process development, optimization, and transfer in a GMP environmentCoordinate manufacturing activities for clinical trials and transition to commercial productionManage raw materials, including supplier qualification, traceability, and risk assessmentCollaborate with QA, RA, Clinical, Supply Chain, and CDMOs in cross-functional teamsSupport quality investigations and risk management activities (ICH Q9, FMEA)Contribute to CMC activity planning and project milestone achievement.REQUIREMENTS AND SKILLS:- Degree in Scientific Disciplines or PhD (Chemistry, Pharmacy, Chemical Engineering, Biotechnology, or related disciplines);- At least 7-8 years of previous experience in CMC;- In-depth knowledge of: ICH Q9/Q10/Q11/M4(R2), FMEA, Quality by Design, technology transfer, analytical method validation, process scale-up, CMC comparability;- Fluent knowledge of English.-Highly desirable: previous experience with nucleic acid manufacturing (mRNA, siRNA, pDNA DP);Soft Skills- Systemic Vision- Problem SolvingADDITIONAL INFORMATION:Place of work: MilanWorking arrangement: hybridThank you for your interest in our organization.Please note that we will only provide feedback to those who are contacted by the Telethon Foundation.We receive a large number of applications and are unable to respond to all of them.Please also note that only candidates who attach their CV to their application will be considered.