Vacancy
Job description
Launched in 2017, the Coalition for Epidemic Preparedness Innovations (CEPI) is an international coalition of governments, academic, philanthropic, private, public, and intergovernmental institutions whose vision is to create a world in which epidemics and pandemics are no longer a threat to humanity. Our mission is to to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has played a central role in the global response to COVID-19, creating the world’s largest portfolio of COVID-19 vaccines – two of which are already saving lives around the world - and co-leading COVAX which is delivering equitable access to COVID-19 vaccines to participating economies worldwide. During this period, CEPI has also overseen several scientific breakthroughs in developing vaccines against other infectious diseases, including the first phase 3 trial of a Chikungunya vaccine and the advancement of the first ever Nipah virus and Lassa virus vaccines into phase 1 clinical trials.
There is an urgent need to do more to mitigate the immediate threat of COVID-19 variants and to prepare now for the next pandemic. As COVID-19 has demonstrated, emerging infectious diseases represent an existential threat to our way of life. COVID-19 is not the first pandemic of the 21st century, and unless we act now, we can be sure that it will not be the last. But unlike some of the other big threats that humanity faces, we have the tools to systematically reduce and even eliminate the risk of future pandemics. It is vital that we capitalise on the rare alignment of political will, practical experience, and technical and scientific progress emerging from the pandemic to prevent such devastation happening again. CEPI has a US$3.5bn five-year plan to tackle the risk of pandemics and epidemics, potentially averting millions of deaths and trillions of dollars in economic damage. This plan will urgently address the immediate threat of COVID-19 variants so we can bring the COVID-19 pandemic to an end; and enable us to prepare now for future threats. This includes our aim to reduce the vaccine development timeline to a 100-day ‘moonshot’ target and to advance the development of broadly protective vaccines that can protect against COVID-19 and its variants, as well as other known or novel coronaviruses.
CEPI is organised as a not-for-profit association under Norwegian Law and has offices in Oslo (HQ), London, and Washington, DC.
In CEPI we strive for diverse thinking, and we want diverse pools of candidates for all our vacancies. We work for an inclusive working environment where each employee can contribute and grow.
More details about CEPI and our mission can be found on our website: www.cepi.net
About the role
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 the vaccines, you influence the lives of many people.
Responsibilities
- Act as CMC Lead in vaccine development projects, and represent CMC at CEPI governance meetings
- Provide CMC and manf 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.
- Contribute to Regulatory initiatives for 100 days mission including development of templates for documentation.
- Collect, share new CMC innovations and new guidance documents.
- Develop partnership with key internal and external stakeholders.
- Degree 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 Biologic process unit operations and control strategies, preferably in multiple platforms
- Knowledge of RNA, viral vectors or subunit vaccine manufacturing and analysis.
- Understands the 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.
- This position can be based in Oslo (Norway), London (UK) or Washington DC (US).
- Experience in the international effort on developing vaccines against emerging infectious diseases and accelerating vaccine development response to outbreaks
- The opportunity to work together with leading internal and external experts on solutions for global challenges
- A diverse and inclusive working environment
