September 16, 2024

cepi

Oslo

Director CMC

Vacancy

Vacancy reference

VAC-0373

Department

Manufacturing and Supply Chain

Location

Oslo / London / Washington DC

Close date

29/09/2024

Job description

About CEPI

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 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 played a central role in the global response to COVID-19, creating the world’s largest portfolio of COVID-19 vaccines – seven of which are approved for global or domestic use - and co-leading COVAX, the global initiative to support equitable access which supported the delivery of over 2bn vaccine doses globally. CEPI has CEPI has contributed to a number of scientific breakthroughs in vaccine development against other infectious diseases, including the first ever licensed Chikungunya vaccine and the first Nipah and Lassa virus vaccines into Phase 1 trials.
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 Manufacturing and Supply Chain (MSC) Division’s primary goal is to support and drive vaccine process development, technical innovations, readiness for 100 Days Mission, and sustainable vaccine manufacturing for equitable epidemic and pandemic preparedness. The division is composed of 3 departments: CMC, MSC Innovations and Manufacturing and Supply Chain Networks, all supported by the Executive Director’s office team. CMC Department oversees and advises on the development, manufacturing, and quality control of vaccine candidates and biologicals, ensuring they comply with regulations, are safe and effective for use, and are fit-for-purpose to deliver on CEPI’s mission.
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.

Education, Experience and Competence

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.

Travel and Location Requirements

Ideally based in London UK, Oslo Norway, or the United States
Up to 30% travel

What we can offer you

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

Background verification maybe conducted to verify information provided in the CV and available documentation.