CMC Lead

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 these vaccines, you influence the lives of many people.

In line with CEPI 3.0 - 2027- 2031 strategy- leveraging AI, this position is expected to guide the design, the construction and deployment of a CMC AI Engine to facilitate and accelerate access to CMC knowledge for development and manufacturing of vaccines.

Responsibilities

• Act as CMC Lead in vaccine development projects and other cross-functional teams, (e.g., viral family and Platform teams).
• Represent the CMC department at the meetings of CEPI governance committees.
• Provide CMC advice and guidance to CEPI awardees 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.
• Act as the business owner for the design and implementation of the AI CMC engine in collaboration with stakeholders internal or external to CEPI (developers, digital teams).
• 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 equivalent (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 modalities (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.
• Familiarity with digital innovation: ability to structure CMC use cases for AI tool development.
• Ability for critical interpretation of complex technical and scientific outcome of AI tools.
• 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.

Travel and Location Requirements

This role can be based in London (UK), Oslo (Norway) or Washington DC (US). Expected international travel up to 30%.

What we can offer you

• The opportunity to work together with leading experts on solutions for global challenges.
• Experience in the international effort on developing vaccines against emerging infectious diseases and accelerating vaccine development response to outbreaks.
• A diverse and inclusive working environment.

How to apply

For more information on how to apply, please visit: https://cepisites.secure.force.com/careers. Should you have any issues submitting your application or have questions please contact jobs@cepi.net.

Background verification will be conducted to verify information provided in the CV and available documentation. Deadline for receiving applications is 22nd February 2026 at 23:59 CET.