Role purpose

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.

Major Duties and 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.

Profile

Core Competencies – functional/technical/behavioural

• 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.
• 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.

Educational and Experience Requirements

• Advanced degree (MSc /PhD) in relevant field.
• Expert in biological manufacturing, drug substance, drug product and assay development.
• Experience in GxP 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.

Terms of Appointment

This is a full-time permanent position. Salary is competitive and commensurate with qualifications and experience. A benefits package is also included.

Role Location

The role is based in London UK, Oslo, Norway, or the United States.

Up to 30% travel.

How to Apply

To apply for this position, please ensure you complete the Application Form provided below by 16 December 2024 (23:59 hrs, GMT -5). It is essential that you submit your CV in English, specifically in Microsoft Word format (.doc/.docx).

Applications in other languages or formats will not be considered.

Rest assured, all information will be handled with the utmost confidentiality.

SRI Executive is exclusively retained by Coalition for Epidemic Preparedness Innovations (CEPI) to undertake this assignment.