Technical Officer (Regulation and Prequalification)

The Technical Officer coordinates the implementation of the antivenom risk-benefit assessment project, managing project activities, conducting dossier reviews, coordinating laboratory testing, assessing compliance with GMP, and providing expert technical advice to support evidence-based decision-making and strategic goals for snakebite programmes.

Responsibilities

• Coordinate the implementation of the antivenom risk-benefit assessment project according to the final work plan and WHO policies.
• Manage day-to-day project activities.
• Conduct dossier review by an independent scientific panel.
• Coordinate establishment of a Technical Services Agreement with an external laboratory for testing of product samples.
• Assess compliance with WHO Good Manufacturing Practice (GMP) of manufacturing sites.
• Perform scientific analysis of data generated during risk-benefit assessments and produce technical reports to support evidence-based decision-making.
• Prepare donor reporting according to agreed timelines.
• Provide internal reporting as required by unit and departmental management.
• Ensure information acquired during risk-benefit assessments is curated in a central data repository in standardized form.
• Coordinate partnership with Wellcome Trust and other partners regarding WHO's antivenom risk-benefit assessment.
• Provide expert technical advice and support to the Department and Unit Head on production, control and regulation of snake antivenom immunoglobulin products to achieve strategic goals for in-country snakebite programmes.

Requirements

• Advanced level university degree (Master's level or above) in Biology, Pharmacy, Chemistry, Biochemistry, Microbiology, Biomedical Sciences or related sciences from a recognized University.
• PhD in one of the fields identified above is desirable.
• At least 7 years of experience in biological standardization and/or the development, production, control and quality assurance of vaccines and biologicals, with experience at both national and international levels.
• Experience in the development/manufacturing and quality control of snakebite antivenoms is desirable.
• Experience in regulation of snakebite antivenoms is desirable.
• Familiarity with WHO prequalification procedures and National Regulatory Authority assessment procedures is desirable.
• Essential knowledge of procedures involved in the risk-based assessment of snake antivenoms.
• Demonstrated previous experience in the area of antivenom assessment and evaluation.
• Solid knowledge of regulatory requirements and variables related to biological products.
• Good understanding of issues related to good manufacturing practices (GMP).
• Knowledge of relevant quality management systems (QMS).
• Expert knowledge of English is essential.
• Expert knowledge of French is desirable.
• Intermediate knowledge of UN language is desirable.

Skills

• Biological Standardization
• Vaccine Quality Assurance
• Biological Product Regulation
• Snakebite Antivenom Development
• Snakebite Antivenom Regulation
• WHO Prequalification Procedures
• National Regulatory Authority Assessment
• Risk-Based Assessment
• Antivenom Assessment
• Good Manufacturing Practices
• Quality Management
• Dossier Review
• Laboratory Testing Coordination
• Technical Advice in Health
• Project Management
• English
• French

Languages

English, French