Head of CMC

The Head of CMC will lead all CMC related activities for assets currently progressing through pre-clinical and/or clinical development or at a commercial stage, including contributing to technical strategy along with management of external CMC vendors and stakeholders. The role holder will work alongside colleagues of Fondazione Telethon and associated stakeholders at the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) in Milan and/or the Telethon Institute of Genetics and Medicine (TIGEM) in Naples. Responsibilities Development of CMC strategy for pre-clinical, clinical and commercial stage projects, including technology transfer, qualification and validation and lifecycle management Evaluation of new CMC equipment and methodologies Definition of process attributes, critical process parameters and specifications Definition of material and drug product shelf life/expiry periods Contribute to the selection and ongoing management of CDMOs for plasmid, vector, raw material and drug product production Develop and maintain strategic partnerships with CDMOs, material and equipment suppliers Contribute to the preparation of CMC aspects of regulatory documentation Oversight of material inventory and supply chain Contribute to process improvement and quality management activities relating to CMC Skills Demonstrated technical experience relating to cell, gene and advanced therapies Experience in developing and executing CMC strategies for therapeutic medicinal products Demonstrated creativity in solving technical, operational and regulatory issues relating to CMC development The ability to plan, coordinate and lead activities simultaneously on multiple projects Experience interacting with the FDA, EMA and European national regulatory authorities. Excellent leadership qualities The ability to interact effectively with all levels of seniority both internally and externally. A track record of ability to handle critical issue situations effectively Excellent communication skills with excellent presentation skills and the ability to work collaboratively Experience of accelerated pathways such as breakthrough designation and Strong organisational and strategic skills Well established negotiating and influencing skills Technical skills University Degree Fluent English We will only consider candidates who will attach their Resume when applying. We thank you in advance for expressing your interest in the Organization. We inform you that, due to the huge amount of applications received, we will be able to provide a feedback only to those who will be contacted from Fondazione Telethon. J-18808-Ljbffr