The VALIDATE Network - Vaccine development for complex intracellular neglected pathogens
Programme Managers - 3Rs in vaccine batch release and quality control testing
Salary: £39,216 - £45,843 (plus London allowances)
Contract type: Three years fixed term (full-time) - possibility to extend if budget is available
The NC3Rs has a strong track record in successfully embedding the 3Rs in the policy, practice and regulations of organisations across the bioscience sector, nationally and internationally. We achieve this through our role as an honest broker, providing an impartial environment for data and knowledge to be shared across companies and sectors as a means for identifying new 3Rs opportunities within current company practice and regulatory requirements.
We are collaborating with the World Health Organization (WHO) to extend these activities to the batch release and quality control testing of vaccines and other biologicals. It has been estimated that more than 10 million animals a year are used worldwide in vaccine development and manufacture and that 80% of these animals are used for routine quality control and batch release tests of licensed products. WHO guidelines and recommendations for the development and manufacture of biologicals carry significant influence and are adopted by a majority of global regulatory authorities, but it is not clear how much animal testing is recommended within them. Opportunities to embed the latest technologies into the development pipeline of biologics are being missed and animal tests that are expensive and often poorly predictive continue to be used.
This three-year project, jointly funded by the NC3Rs and the Bill and Melinda Gates Foundation, will:
Review existing WHO biologics and vaccines guidelines for requirements of animal testing in product control and release testing
Evaluate the barriers to acceptance and adoption of 3Rs practices among biologics manufacturers, national control laboratories and WHO member states;
Develop a set of recommendations for the inclusion of 3Rs methods within existing WHO guidelines for human vaccines and biologics.
Widescale implementation of the recommendations will enable vaccines manufacturers and regulators to apply the latest non-animal testing approaches and strategies to support faster access to cheaper vaccines by the global communities who need them most urgently.
The main responsibilities of the Programme Manager include:
Developing surveys and analysing survey data to gather an evidence-base to support the development of recommendations for the inclusion of 3Rs methods in WHO guidelines.
Convening an expert working group and supporting the work on reviewing WHO guidelines for opportunities to include the 3Rs.
Organise working group meetings including preparing the agenda, meeting minutes and overseeing delivery of action points.
Preparing annual project update reports for the working group and project funders.
Organising international workshops and symposia to engage the global biologics community in the project and to understand regional barriers and opportunities for the adoption of 3Rs approaches.
Prepare workshop reports/publications and other dedicated communication materials to promote the outputs from the project.
Building strong relationships both internally and externally.
Delivering NC3Rs' programme to support the adoption of the 3Rs in the biologics field.