CMC Manager

RESPONSABILITY:

• Defining and implementing the CMC and Quality by Design (QbD) strategy for assigned programs
• Supporting CMC regulatory activities and dossier preparation (IND, IMPD, BLA, MAA)
• Manage control strategy, stability, and comparability, assessing the regulatory impact of manufacturing and analytical changes
• Oversee process development, optimization, and transfer in a GMP environment
• Coordinate manufacturing activities for clinical trials and transition to commercial production
• Manage raw materials, including supplier qualification, traceability, and risk assessment
• Collaborate with QA, RA, Clinical, Supply Chain, and CDMOs in cross-functional teams
• Support 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 Solving

ADDITIONAL INFORMATION:

Place of work: Milan

Working arrangement: hybrid

Fondazione Telethon is one of Italy’s leading charities. Since 1990, 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.