Description We are currently looking for a Principal Scientist - Formulation Science to join our Research & Development function within the Science, Research & Innovation group. Please note this opportunity is currently only available to those working within the Civil Service. Applications from non-Civil Servants may not be reviewed and may be rejected. This is a full-time opportunity, on a permanent basis. The role will be lab based in South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas. We are open to flexible working requests, please discuss this with the hiring manager before accepting an appointment. Who are we? 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, Research and Innovation Group (SR&I) delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety. The SR&I Research & Development (R&D) function will deliver statutory mandated strategically aligned, sustainable and impactful Regulatory Scientific research that is applied primarily to biological reference materials development and medicines control testing in areas of international and national priority for future biological medicines. Research and Development will host and nurture the current excellence in research into biological reference materials, biological activity measurements, product quality testing and standardisation that is currently hosted by the National Institute for Biological Standards and Control (NIBSC). Analytical and Biological Sciences (ABS) is a multi-laboratory, multi-disciplinary team of experts within R&D. Both in vitro and in vivo methods are used to deliver practical laboratory analysis, experimentation and expertise aligned with the Agency’s objectives. The Formulation Science team not only contribute to site-wide projects but also pursue their own research areas in collaboration with industrial and academic colleagues in their respective field. Their role is to develop suitable formulations and lyophilisation processing conditions and carry out supportive research in order to facilitate the reference material program of the SR&I Group. What’s the role? The Principal Scientist will have hands-on responsibility for the routine trial development work and leading approved research and development related to the area of Formulation Science and will report to the Section Head, Formulation Science. They will have delegated line management duties within the team for one grant funded post and others may be added. This role is the contact point for the development of lyophilization conditions for all freeze-dried standards under development within SR&I. Key responsibilities: Perform research and development activities related to formulation and freeze drying of biological materials to achieve SR&I’s and the Agency’s goals. Provide hands on expertise of trial formulation and freeze-drying conditions for all biological standards prepared at our Science Campus, requiring lyophilization. Contribute to an Internationally recognised research program related to freeze drying and formulation of biologicals. Interact closely with the Head of Standards Production and other CBRM Managers to participate, advise, troubleshoot and influence the direction of the operation and exploitation of the CBRM resource to SR&I and the Agency’s benefit. Promote the MHRA brand as a resource/expertise in lyophilization with an expectation of publishing in peer reviewed papers and presenting at relevant conferences. Who are we looking for? Our successful candidate will have: Postgraduate qualification in relevant scientific subject area, protein chemistry, analytical chemistry, along with experience of supervising in a laboratory setting. Thorough understanding of the development process and role of International Standards and reference materials and wider metrology issues with the quantitation of biological medicines. Proven track record of contributing to research programs and active research collaborations with other researchers nationally and worldwide. Substantial relevant experience and familiarity in formulation freeze drying of biological reference materials, operating to ISO 9001, GMP and other regulatory guidelines. Demonstrable Behaviours of Developing Self and Others, Working Together, and Delivering at Pace. If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! 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. 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. 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 Technical criteria. 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 Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own. If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible. Closing date: 12 September 2025 Shortlisting date: 15 September 2025 Interview date: 25 and 26 September 2025 Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome. 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 whether you are able to apply is available here. Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks. Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include: Laboratory-based roles working directly with known pathogens Maintenance roles, particularly those required to work in laboratory settings Roles that involve visiting other establishments where vaccination is required Roles required to travel overseas where specific vaccination may be required. Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government. Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here. Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk. In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Florentina Oyelami, Head of Talent Acquisition – Florentina.Oyelami@mhra.gov.uk. If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk info@csc.gov.uk Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ