Cell and Gene Therapy Technical Lead

Job title:

Cell and Gene Therapy Technical Lead

Company

Alexion Pharmaceuticals

Job description

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.You will be responsible for:

• 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.

You will need to have:

• BSc in Cell Biology, Biochemistry, Molecular Biology (or other gene therapy related field) with at least 15 years of experience in either the pharmaceutical industry or academic setting, with at least 5 years industry experience in the area of Cell or Gene Therapy.
• In-depth knowledge of AAV product development and manufacturing and will have experience of transient transfection and producer cell line systems.
• Prior experience of bringing Cell or Gene Therapy products through GMP manufacturing, validation and regulatory submission.
• Strong knowledge of GMP practices and regulatory requirements from FDA and other global health authorities.
• Strong leadership skills and demonstrated ability to collaborate and build relationships.
• A strong understanding of the drug development pathway through commercialization and risk management, and ideally experience of bring a cell and gene therapy product to market.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Higher degree (Masters /PhD) in Cell Biology, Biochemistry, Molecular Biology, Virology, Genetics or equivalent scientific discipline is preferred.

Proven track record of technical leadership in bringing Cell or Gene Therapy products through validation and reglatory approvalAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Expected salary

Location

Dublin

Job date

Sat, 20 Jul 2024 22:14:33 GMT

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