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Medicines and Healthcare products Regulatory Agency

Senior Scientist

Hertfordshire
Posted about 15 hours ago
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This vacancy is open to all Civil Service employees and employees of accredited non-departmental public bodies (NDPBs) who were appointed on merit following a fair and open competition; or were appointed to a permanent post through an exception in the Civil Service Commissioners' rules.

We are currently looking for a Senior Scientist to join our Standards Lifecycle Team within the Science and Research Group.

This is a full-time opportunity, on a permanent basis. The role will be based at South Mimms, Hertfordshire.

About Us

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The Science and Research Group delivers public health impact through 4 sub-Groups: Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.

Standards Lifecycle produces the MHRA biological reference materials. Marketed using the NIBSC brand, the Agency is a global leader in the standardisation and control of biological medicines and related diagnostic tests and is responsible for developing and producing over 90% of the World Health Organisation (WHO) International Standards in use around the world to assure the quality of these important products. The function is responsible for the WHO and other categories of Reference Materials and develops them from research and prototype materials through to completed validated products including manufacture and distribution.

What’s the Role?

The primary purpose of the role is to lead and deliver prioritised standardisation projects relating to bacterial vaccines and infectious diseases, including the delivery of projects to establish new reference materials as well as projects that will ensure existing reference materials are replaced, maintaining continuity of International Units where applicable. The role will lead standardisation projects and will use their experience and knowledge of biological standardisation (in the field of bacterial vaccines and infectious disease) to support other team members with delivery of standards projects. The role will liaise with colleagues across the Agency to provide scientific expertise related to biological standardisation and analytical methods where appropriate and will manage relationships with external stakeholders, including collaborative study participants and the World Health Organisation (WHO), to ensure that standardisation projects are progressed and delivered to agreed timelines.

Key Responsibilities:

  • Lead projects, in compliance with relevant quality management systems, to develop and characterise (via large multi-laboratory collaborative studies) biological reference materials that support standardisation of assays used to evaluate bacterial vaccines/antigens or the response to immunisation
  • Analyse and interpret complex data sets, keeping accurate records, to build evidence and inform design of future studies; actively communicate findings through written reports, scientific publications and delivery of scientific presentations in relevant fora
  • Monitor performance of established reference materials via a combination of routine use, ongoing stability assessment and review of feedback from internal and/or external users of materials provided by the Agency
  • Engage with national and international external stakeholders, including other National Control Laboratories, WHO, the European Directorate for the Quality of Medicines and Healthcare, academic institutes or contract testing clients as required to further standardisation objectives, deliver expert services, training and/or scientific or technical advice as required

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Who Are We Looking For?

  • Ability to encourage joined up teamwork within own team and across other groups. Establish professional relationships with a range of stakeholders
  • Experience with performance and standardisation of assays used to evaluate or quantify vaccines/antigens, bacteria or the response to immunisation
  • Experience of successfully delivering multi-stakeholder projects to establish new or replacement standards consisting of one or more of the following types of material: protein antigens, toxin/toxoids, polysaccharide antigens, antisera, monoclonal antibodies, whole cell standards, nucleic acid standards
  • Good understanding of the principles of biological standardisation and its application to a range of assay models
  • Well-developed technical skills in one or more of: immunological assays, mammalian or bacterial cell culture, recombinant protein production and purification, neutralisation or bactericidal assays, molecular biology techniques

Person Specification:

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation

Behaviour Criteria:

  • Working Together (A, I)
  • Communicating and Influencing (A, I)

Experience Criteria:

  • Experience with performance and standardisation of assays used to evaluate or quantify vaccines/antigens, bacteria or the response to immunisation (A, I)
  • Experience of successfully delivering multi-stakeholder projects to establish new or replacement standards consisting of one or more of the following types of material: protein antigens, toxin/toxoids, polysaccharide antigens, antisera, monoclonal antibodies, whole cell standards, nucleic acid standards (A, I)
  • Experience of analysing and interpreting complex data sets (A, I)
  • Experience of working under a quality management system (A, I)
  • Experience with handling hard-to-grow aerobic and anaerobic bacteria is desirable (A, I)
  • Practical experience with animal models of potency or immunogenicity is desirable (A, I)

Technical Criteria:

  • A BSc or higher degree in a relevant scientific discipline combined with relevant post-graduate laboratory experience (A, I)
  • Well-developed technical skills in one or more of: immunological assays, mammalian or bacterial cell culture, recombinant protein production and purification, neutralisation or bactericidal assays, molecular biology techniques (A, I)
  • Good understanding of the principles of biological standardisation, with broad knowledge of the development and application of bacterial vaccine standards for the quality control and regulation of biological medicines (A, I)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification [https://mhra-gov.filecamp.com/static/files/evUmhSzDlWAw3G5F.pdf]!

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Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk

The Selection Process:

We use the Civil Service Success Profiles to assess our candidates, find out more here [https://www.gov.uk/government/publications/success-profiles].

  • Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. Please ensure not to include any personal identifying information on your supporting information.
  • Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Experience with performance and standardisation of assays used to evaluate or quantify vaccines/antigens, bacteria or the response to immunisation.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

Use of AI in Job Applications

Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance [https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.civil-service-careers.gov.uk%2Fartificial-intelligence-and-recruitment%2F&data=05%7C02%7CUfuoma.Eriemo2%40mhra.gov.uk%7C3d175bf263f54c3cf85608de3bfa288f%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C639014142773052769%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2VE8qZPdzo8azEL775DBoKUPz5zMHopZPjc9cs3KuOk%3D&reserved=0]for more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

Important Dates:

  • Closing date: 7th August 2026
  • Shortlisting date: from 11th August 2026
  • Interview date: from 17th August 2026

If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on

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Skills

Biological Standardisation
Project Management
Immunological Assays
Mammalian Cell Culture
Bacterial Cell Culture
Recombinant Protein Production
Protein Purification
Neutralisation Assays
Bactericidal Assays
Molecular Biology Techniques
Data Analysis
Quality Management Systems
Stakeholder Management
Scientific Writing
Vaccine Evaluation

Location

Hertfordshire, England, United Kingdom

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