Description:
The purpose of the role is to ensure that CEPI provides effective support to developers throughout the development of their vaccines and act as the CMC expert to progress and accomplish CEPI’s mission. By transforming innovative science into valued new vaccines and ensuring that people around the world can access these vaccines, you influence the lives of many people.
Responsibilities
- Act as CMC Lead in vaccine development projects and other cross-functional teams, e.g., priority pathogen disease teams, and represent CMC at CEPI governance meetings.
- Provide CMC advice and guidance to CEPI funded projects in all development phases, including preparation of CTM documentation.
- Evaluate CMC development according to CEPI’s CMC framework, with project-specific CMC roadmaps that embed Line-of-Sight for future (commercial) supply from LMIC sites in a phase-optimized manner.
- Contribute to publish calls-for-proposal and perform due diligence for vetting.
- Participate in regulatory initiatives supporting CEPI’s 100 Days Mission, including development of templates for documentation.
- Gather and disseminate new CMC innovations and new guidance documents.
- Develop partnerships with key internal and external stakeholders.
Education, Experience and Competence
- Degree in Bioengineering, Pharmacist or similar (advanced degree preferred).
- Minimum 5 years of experience in a CMC role in pharmaceutical or biotechnology industries, not-for-profit organisation.
- Experience in leading CMC/process or analytical development projects.
- Strong knowledge of biological process unit operations and control strategies, preferably on multiple platforms.
- Knowledge of RNA, viral vectors, or subunit vaccine manufacturing and analysis.
- Understanding of vaccine development processes and strategies for development programmes, including best practices in tech transfer.
- Knowledge of CMC regulatory guidance and required documentation.
- Excellent oral and written communication skills in English.
- Leadership skills, with the ability to build trust with internal and external partners and work in a matrix way in an international environment.
- Strong interpersonal skills, team player, able to work in different cultural environments, to negotiate timelines and develop effective international collaboration.