Norway Job Openings
cepi
Director CMC
Oslo
September 16, 2024
Vacancy
Job description
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. 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’s five-year plan for 2022-2026 – known as CEPI 2.0 - aims to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI’s goal to accelerate the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this ‘100 Days Mission’, which has been embraced by the G7 and G20, would give the world a fighting chance of containing a future outbreak before it can spread to become a global pandemic, potentially averting millions of deaths and trillions of dollars in economic damage.
CEPI is 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 a diverse pool 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 Director CMC, reporting to the ED Manufacturing and Supply Chain division (MSC), leads the CMC department to enable CEPI’s product development projects towards successful commercialization, stockpiling of clinical material or contribute to process platform pandemic readiness. The Director ensures that CMC development efforts align with CEPI’s 100 DM and equitable access objectives. This role requires close collaboration with other MSC departments, the R&D team and external partners to ensure all activities are aligned with the objective of each project.
Responsibilities
- Lead and develop the experienced CMC team to enable the execution of the Disease team projects and department tasks
- Responsible for the CMC operating budget
- Lead development and execution of CMC strategy in alignment with CEPI and MSC strategies
- Ensure effectiveness and efficiency of project milestones and project budget control for the CMC area– ensuring timely reviews for effective decision making and documentation transfers
- Member of the MSC LT and CEPI ELT
- Lead CMC activities, e.g. develop new tools and knowledge to enable vaccine development using various platforms having CEPI’s strategy on 100 DM and Equitable access in scope
- Act as CMC-L in some vaccine development projects and support knowledge sharing across CEPI and the division
- In close collaboration with other MSC, R&D and wider CEPI departments support CMC activities to match innovative technology and manufacturing facilities to product development projects
- Contribute to Vaccine/biologics development ecosystem by publishing CEPI and CEPI partners achievements and guidance documents.
- Advanced degree (MSc /Ph D) in relevant field
- Minimum 10 years of experience in the pharmaceutical industry and/or relevant government/non-profit organization, with proven track record in strategic planning, execution, and CMC development
- Broad understanding of end-to-end vaccine development from discovery to late-stage development and current challenges in vaccine development
- Expert in biological manufacturing, drug substance, drug product and assay development
- Experience in Gx P and working with regulatory agencies on CMC issues and compiling files for regulatory submissions
- Experience working across cultures and countries (internationally) is preferred
- Experienced in delivering CTM to clinical trials
- Experience with manufacturing targeting endemic regions of low to middle-income countries a plus
- Demonstratable leadership and management skills at all levels and within highly matrixed organizations
- Able to operate and adapt successfully in a frequently changing environment
- Outstanding technical written, verbal and interpersonal communication skills - Concrete communicator and motivational facilitator
- Strong interpersonal skills, able to work in different roles in various projects and cultural environments, to reach consensus and develop effective international collaboration.
- Ideally based in London UK, Oslo Norway, or the United States
- Up to 30% travel
- 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
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