CMC Project Manager

The Company

AAVantgarde is a clinical-stage, international biotechnology company headquartered in Italy. We have developed two cutting-edge AAV vector platforms to overcome DNA cargo limitations, targeting Usher syndrome type 1B and Stargardt disease. Founded by the renowned Professor Alberto Auricchio, a pioneer in gene therapy, our mission is to transform genetic medicine for patients with no current therapeutic options. Join us at AAVantgarde and be a part of our innovative journey to bring the next generation of genetic medicines to those in need.

The Role

We are seeking a highly skilled and proactive CMC Project Manager to oversee the CMC activities supporting our gene therapy programs. This pivotal role will involve coordinating cross-functional teams to ensure the seamless execution of CMC strategies and delivery of high-quality gene therapy products in compliance with regulatory standards. The successful candidate will play a critical role in managing timelines, internal teams, and external partnerships, ensuring the alignment of CMC activities with company objectives. This role reports to the Director of External Manufacturing.

1. Oversee the planning and timely delivery of all CMC-related project activities at our CDMOs, including process development, analytical development, technology transfer, manufacturing, and quality control.
2. Ensure the CMC plans are in alignment with the Program objectives.
3. Facilitate cross-functional team meetings, providing updates on project progress, challenges, and solutions.
4. Foster effective communication and alignment between the technical teams, Quality Assurance, Regulatory Affairs, and Supply Chain.
5. Develop and maintain detailed project timelines and weekly project dashboards.
6. Own the risk and issues register, including mitigation plans across all stages of CMC development and manufacturing.
7. Oversee the project-related budget.
8. Capture all key decisions and keep an action tracker that is proactively managed.

Skills and Experience Required

The successful candidate will have a bachelor's degree in science or an engineering discipline, ideally with an accredited PM qualification (PRINCE2/AgilePM/PMP). You will have a minimum of 8 years of experience, 3 of which should be within the biotech or pharmaceutical industry, preferably with a focus on cell and gene therapy. You will have demonstrated experience working for, or with, CDMOs. You will also be proficient in project management tools and software (e.g., MS Project, Smartsheet, etc.).

What's in it for You

At AAVantgarde, we believe in creating an environment where our employees can thrive. Our flexible working environment allows you to balance work and life effectively. Our central London office, just a stone's throw from London Victoria train station, offers a prime location with top-notch facilities including a gym, coffee shop, and a rooftop garden. As a rapidly growing biotech with recent funding, there are ample opportunities for career advancement, and as we grow, so can you. We offer a generous salary, bonus, pension, health insurance through Vitality, and income protection, ensuring you have the support and resources you need to succeed. Join us and be part of an exciting, innovative journey in the world of biotechnology.

Equal Opportunities

At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.