| Position Title | Senior Technical Advisor (diagnostics expert) – MADE Project |
| Job Type | Full-Time |
| Duty station | Africa based – preferably Kenya, Uganda, Nigeria, Ghana, Senegal |
| Type of Contract |
Fixed Term Contract |
ASLM Background
The African Society for Laboratory Medicine (ASLM) is a Pan‐African professional body, working to advocate for the critical role and needs of laboratory medicine and networks throughout Africa. Africa is rapidly growing but faces major health challenges including epidemics of HIV, tuberculosis, and malaria, and new priorities such as Ebola and other global health security threats. Strengthened laboratory capacity and surveillance in Africa are critical to overcoming the burden of disease and ensuring a healthy future for the continent. ASLM addresses these challenges by working collaboratively with governments, local and international organizations, implementing partners, and the private sector.
ASLM is working within the Unitaid funded PATH led consortium on Manufacturing to Accelerate Diagnostic Excellence (MADE) in Africa project, which forms part of Unitaid’s Regional Manufacturing for Equitable Access portfolio. The project aims to fulfill the goals of existing efforts to strengthen Africa’s diagnostic supply landscape by supporting the development and scaling availability of regionally manufactured affordable, high-quality diagnostics in alignment with existing regional and continental efforts. By developing regional capacity, the MADE consortium aims to reduce import dependency, improve health outcomes, and build a more self-reliant and responsive health care ecosystem across the continent.
Purpose of the role
Working closely with the MADE consortium technical director, the Senior Technical Advisor will provide cross-cutting technical, regulatory, and operational advisory support Africa-based diagnostics manufacturers. The role focuses on capacity building, diagnostic evaluation readiness, quality management systems (QMS), regulatory strategy, and ensuring sustainability of technical assistance through structured knowledge transfer to African institutions and manufacturers. The Advisor will support implementation of the MADE project workplan and also contribute to the continental regulatory harmonization and pandemic preparedness and response (PPPR) objective.
The postholder’s key responsibilities include but are not limited to the following
- Provide tailored advisory support to manufacturers producing malaria, HIV, and HIV/syphilis diagnostics, including SOP development, QMS documentation, manufacturing operations, and R&D pipeline strengthening to ensure production of quality-assured diagnostics.
- Assess and strengthen capacity of CoEs to conduct diagnostic test evaluations, including development of well-characterised samples, and improvement of clinical/evaluation studies, timelines, and compliance.
- Provide hands-on technical assistance to manufacturers on quality management systems, regulatory strategy, study design, SOPs, design control, and assay validation across R&D, manufacturing, and operations.
- Guide manufacturers to ensure QMS procedures are fit for purpose, compliant with applicable standards, and aligned with product development and evaluation scopes.
- Support continental registration and local manufacturing initiatives by contributing to model policies, guidance, and sustainability strategies through DAC and AMA-aligned processes.
- Lead structured knowledge transfer and transition of technical assistance capabilities from PATH and International experts to ASLM teams, membership and selected manufacturers to enable long-term, regional/local technical support.
- Support CoEs to develop training material across key technical areas including QMS, R&D, manufacturing processes, regulatory and product registration and commercialisation of new diagnostics.
- Contribute to MADE project planning, re-budgeting, reporting, and coordination to ensure timely and effective delivery of cross-cutting and company-specific activities.
Qualification:
- Advanced degree in biomedical/laboratory sciences, pharmacy, public health, engineering, or a related field.
- Minimum 8–10 years of experience in diagnostics development, manufacturing, or QMS
- Demonstrated experience conducting diagnostic evaluation studies.
- Strong knowledge of international IVD quality and regulatory standards or frameworks (e.g., ISO 13485, FDA 21 CFR 820, WHO prequalification, regional regulatory pathways).
- Proven experience delivering technical assistance, training, and capacity-building programs.
- Excellent stakeholder engagement, communication, and project management skills.
- Willingness and ability to travel extensively across Africa
Desirable
- Demonstrated experience supporting LMIC-based manufacturers
- Experience with clinical and regulatory affairs for IVDs
Core Competencies
- Technical leadership in diagnostics and manufacturing
- Capacity building and adult learning
- Regulatory and quality systems expertise
- Stakeholder coordination and partnership building
- Strategic thinking with hands-on execution
Equal opportunity
ASLM is an equal opportunity employer, and we recruit and select staff based on their demonstrated ability, qualifications and suitability for work.
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