CEPI (Coalition for Epidemic Preparedness Innovations) · 1 day ago
CMC Lead
United States
Full-time
Remote
Senior Level
5+ years expCEPI (Coalition for Epidemic Preparedness Innovations) is an international coalition dedicated to accelerating the development of vaccines against epidemic and pandemic threats. The CMC Lead will ensure effective support to vaccine developers and guide the design and deployment of a CMC AI Engine to facilitate access to CMC knowledge.
Research
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
Qualification
Required
Degree in Bioengineering, Pharmacist or equivalent
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
Preferred
advanced degree preferred
Benefits
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
Company
CEPI (Coalition for Epidemic Preparedness Innovations)
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, 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.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Mats Olsen
Access and Private Partnerships | Business Development Senior Manager
Recent News
2026-02-04
2026-02-04
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