Technical Officer (Regulation and Prequalification)

Overview

Coordinates the implementation of the antivenom risk-benefit assessment project and provides expert technical advice on the production, control, and regulation of snake antivenom immunoglobulin products.

Key Responsibilities

• Day-to-day management of project activities.
• Conduct of dossier review by an independent scientific panel.
• Coordination of the establishment of a Technical Services Agreement with an external laboratory for product testing.
• Assessment of compliance with WHO Good Manufacturing Practice (GMP) of manufacturing sites.
• Scientific analysis of data and production of technical reports.
• Donor and internal reporting.
• Curation of information in a central data repository.
• Coordination of partnership with Wellcome Trust and other partners.
• Provision of expert technical advice to the Department and Unit Head.

Required Experience

At least 7 years of experience in biological standardization and/or the development, production, control and quality assurance of vaccines and biologicals. Experience at both the national and international level. Experience in the development/manufacturing and quality control of snakebite antivenoms. Experience in regulation of snakebite antivenoms. Familiarity with WHO prequalification procedures and National Regulatory Authority assessment procedures.

Qualifications

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.

Other Details