We are currently recruiting for the following role:
Programme Manager – 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
Science-led and evidence-based, the NC3Rs is the UK’s national organisation for the 3Rs, established in 2004 to accelerate the development and uptake of new models and tools that replace, reduce or refine the use of animals in research and testing. The NC3Rs is primarily funded by Government and has an annual budget of approximately £10 million. Its activities are divided between its role as the UK’s major 3Rs research funder and programmes led by its own team of scientists. Further information can be found at www.nc3rs.org.uk.
Role of the Programme Manager
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.
Qualifications, knowledge and experience
- PhD in a biological science.
- Vaccines/biologics research and development (preferably post-licensure) and significant post-doctoral experience, or industry equivalent.
- Knowledge/experience of biologics regulatory landscape (desirable but not essential).
- Knowledge/experience of WHO biologics guidelines (desirable but not essential).
- Proven experience in organising and running large workshops and symposia.
- Proven experience in reviewing scientific publications and manuscripts.
- Experience of prioritising and planning workload to meet multiple and/or tight deadlines without compromising quality or working relationships.
There will be no formal staff management responsibilities.
The successful candidate will be subject to security checks.
The closing date for applications is Friday 14 August.
Please visit the MRC vacancy portal for further information, including how to apply.
Please ensure you include a copy of your CV and a covering letter. Your cover letter should outline and explain how you meet the criteria listed in the person specification for this position.
Interviews will take place on Wednesday 2 September.
Choosing to come to work at the NC3Rs means that you will have access to a whole host of benefits including a generous occupational pension scheme and excellent holiday entitlement.