Cell and Gene Therapy Technical Lead

at  Alexion PharmaceuticalsInc

Location: Dublin, Ireland
Job reference: R-200478
Date posted: 05/24/2024
Alexion is committed to developing a variety of Genomic Medicines for the treatment of rare diseases. We have a portfolio of Adeno-Associated Virus (AAV) vectors that are being developed to deliver novel genetic therapies to patients for disease prevention and treatment, spanning multiple disease areas. We will also explore other Genomic Medicine modalities for the prevention and treatment of rare diseases, including non-viral vector delivery, Gene Editing, and ex vivo Cell Therapies.
Cell and Gene therapy manufacturing technology is advancing rapidly and the Alexion Operations team recognises that it is vital to have a robust manufacturing infrastructure in place to ensure that patients can access therapeutics as efficiently as possible.
We are seeking a highly experienced and motivated individual to join the Technical Operations team to help develop the manufacturing and supply strategy for these novel therapies and to provide technical input to the development of these products. This individual will work closely with other CMC and Operations functions to ensure harmonized strategies are executed to ensure on-time delivery of cell and gene therapy products through clinical development and through to launch.

• Provide leadership and support to the identification, evaluation and selection of partners for the supply and of starting materials, drug substance and drug product
• Provide leadership and support to the identification, evaluation and selection of manufacturing technologies.
• Providing technical leadership to the development of the manufacturing strategy for Alexion’s Genomic Medicine portfolio, including input Make versus Buy decisions.
• Serve as a Subject Matter Expert and establish internal guidelines, procedures and business processes for the manufacture of Genomic Medicines
• Serve as a Subject Matter Expert during internal and external audits.
• Assist Alexion’s business development teams and serve as a Subject Matter Expert during due diligence of potential BD deals.
• Partner with other CMC functions to create and implement a tech transfer, manufacturing and testing strategy for Contract and Development Manufacturing Organisations (CDMOs) services for viral vector and cell therapy production.
• Partner with other CMC functions to ensure appropriate process design and process understanding for successful PPQ and commercial manufacturing
• Provide oversight of external manufacturing activities at CDMOs to assure on-time supply of preclinical and clinical materials which meets quality, compliance, and regulatory requirements.
• Continually update knowledge and understanding in the field of cell and gene therapy.