Feasibility and Concept Design Expert

**Request for Proposals**
**Feasibility and Concept Design Expert**
**- GMP mRNA Vaccine Manufacturing in Africa**:
**Location**:_ Remote (with possible travel to Africa)_
**Type of assignment**:_Consultancy _

**BACKGROUND**:
The Medicines Patent Pool (**MPP**), a non-profit organization based in Geneva, Switzerland, works to increase access to life-saving medicines and health technologies in low
- and middle-income countries (LMICs). In partnership with the World Health Organization (**WHO**), MPP co-leads the **mRNA Technology Transfer Programme**, a global initiative designed to establish sustainable and locally owned mRNA vaccine manufacturing capacity in LMICs.

The Programme supports the development and transfer of an mRNA technology, technical training, and R&D initiatives. It works through a consortium model where technology and know-how are developed by and transferred from a consortium in South Africa to a network of recipient manufacturers (Programme Partners) in LMICs. Its mission is to enable equitable access to mRNA vaccines and therapeutics, initially focusing on the COVID-19 vaccine as a proof-of-concept pathogen but expanding to other diseases of interest for LMICs, including HIV, TB, Malaria, Thx HPV, Mpox.

**THE ROLE**:
**MPP is seeking an Expert Consultant to assess the feasibility and design of commercial Good Manufacturing Practice (GMP) mRNA vaccine manufacturing at two African partner sites, one of which is an existing facility and the other a greenfield project. In addition to these site-specific assessments, the consultant will conduct a continent-wide diagnostic of current mRNA manufacturing capacity and supply chain infrastructure.

The objective is to assess Africa’s capacity for vaccine production, emphasizing mRNA technology alongside other platforms, and to provide a strategic roadmap to address infrastructure, supply chain and operational needs for local vaccine manufacturing.

The consultant’s work will directly contribute to shaping an action plan for future vaccine production capacity and supply chain strengthening in Africa.

**SCOPE OF WORK**:
**Site-Specific Feasibility and Concept Design (Two Manufacturers)**:

- Assess feasibility for establishing or expanding commercial GMP mRNA vaccine manufacturing at two African manufacturing partners:

- One brownfield site (existing infrastructure)
- One greenfield site (new facility)
- Evaluate facility readiness, technical capabilities, utilities, compliance with GMP standards, and scalability.
- Outline concept design elements and high-level investment estimates to fill the identified gaps.

**Africa-Wide Capacity and Infrastructure Diagnostics**:

- Conduct a diagnostic of current and potential mRNA vaccine manufacturing capacity across Africa, including production volumes, capabilities, and geographical distribution.
- Assess existing vaccine manufacturing infrastructure and identify key requirements to adapt it to the production of mRNA-based products (Drug Substance and Drug Product).
- Identify gaps in the mRNA vaccine supply chain across the continent, covering:

- Sourcing and availability of raw materials
- Fill-finish capabilities
- Cold chain logistics and distribution

**Strategic Outputs and Roadmaps**:

- Produce a factsheet summarizing current African mRNA vaccine capacity (in number of doses per year).
- Develop a techno-economic roadmap to bridge identified manufacturing capacity gaps.
- Develop a supply chain roadmap with actionable recommendations for strengthening regional resilience.

**EXPECTED RESULTS**:
The diagnostic work conducted by the consultant will inform:

- **An action plan** to bridge manufacturing capacity gaps for mRNA vaccine production in Africa.
- **An action plan** to address weaknesses in the mRNA vaccine supply chain, from raw material sourcing to regional distribution.

**QUALIFICATIONS AND EXPERIENCE REQUIRED**:

- Proven experience in GMP vaccine manufacturing facility design, feasibility studies, or engineering consulting.
- Deep understanding of mRNA platform technologies and their manufacturing process requirements.
- A track record of successfully leading technical assessments or design projects for vaccine manufacturing (drug substance, drug product, or both).
- A strong understanding of regulatory requirements for commercial vaccine manufacturing.
- Familiarity with supply chain logistics for vaccines, including cold chain.
- Prior experience working in Africa
- Prior experience working with global health organizations is strongly preferred.
- Excellent analytical, communication, and reporting skills, including the ability to present findings to technical and non-technical audiences.

**PROPOSAL SUBMISSION REQUIREMENTS**:

- A cover letter outlining their experience and suitability for the consultancy.
- A detailed CV, highlighting relevant expertise in vaccine manufacturing, GMP facility design, and infrastructure diagnostics.
- Examples of similar work or studies conducte