Contents Location About the job Benefits Things you need to know Apply and further information Location South Mimms, Hertfordshire About the job Job summary We are currently looking for a Head of Formulation Science to join our Analytical & Biological Sciences team within the Science, Research & Innovation group. This is a full-time opportunity, on a permanent basis. The role will be based in South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas. Government departments and agencies are working towards implementing a minimum 60% attendance in office sites. We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. 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. R&D 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 MHRA Science Campus, previously known as National Institute for Biological Standards and Control (NIBSC). Job description Whats the role? 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 the Agency 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. This role is very important to our standards production and external filling contracts, and due to the small size of the team, the person who takes on this role will not only provide leadership and expert knowledge in the stabilization and formulation of biologics, focusing on research, development, and freeze-drying (lyophilization) processes, but also have a hands on approach for the role. This role encompasses managing a team, directing an internationally recognized research program, and delivering impactful service through collaboration, commercialization, and regulatory compliance. Key responsibilities: Lead and line manage the Formulation Science Section within the ABS Division. Lead research and development activities related to formulation and freeze drying of biological materials to achieve SR&Is and the Agencys goals. Provide expert advice and subsequent implementation of trial formulation and freeze-drying conditions for all biological standards prepared at MHRAs Science Campus requiring lyophilization. Promote the MHRAs Science Campus research work and capabilities through national/international forums as a resource/expertise in lyophilization with an expectation of publishing in peer reviewed papers and presenting at relevant national and international conferences. Act as SR&Is central point of contact with the National Measurement System, attending the UK Measurement Forum and as a delegate observer at the Professional Expert Groups of the National Physical Laboratory and National Measurement Laboratory (at LGC). Person specification Our successful candidate will be able to demonstrate how they meet the following criteria: Scientific Expertise : Strong familiarity/understanding across a very broad range of scientific disciplines e.g. across haematology, biochemistry, immunology and microbiology/virology, especially in areas related to the development and characterization of biological medicines & reference materials to control them. Delivering at Pace : Ability to lead teams effectively, set clear expectations, and ensure the timely delivery of high-quality outcomes while complying with legal and regulatory standards. Demonstrates resilience and maintains performance under pressure. Research Leadership : Proven experience in maintaining and developing research programs, securing grant funding, and publishing in peer-reviewed journals. Demonstrates confidence in presenting complex data to diverse audiences. Developing Self and Others : A commitment to continuous learning and development, both personally and for the team. Supports individuals to take responsibility for their learning and ensures equal access to development opportunities. Project and Resource Management : Experience in setting up and maintaining a laboratory environment with complex equipment, managing projects effectively, and familiarity with ISO 9001, GMP, and other regulatory guidelines. Prince 2 qualification or equivalent experience is desirable. 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 careersmhra.gov.uk Benefits Alongside your salary of £73,324, Medicines and Healthcare Products Regulatory Agency contributes £21,241 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides. Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays Privilege Leave: 1 day Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666 Flexible working to ensure staff maintain a healthy work-life balance Interest free season ticket loan or bike loan Employee Assistance Services and access to the Civil Service Benevolent Fund Eligibility to join the Civil Service Motoring Association (CSMA) Variety of staff and Civil Service clubs On-going learning and development Things you need to know Selection process details 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. Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage. 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 PhD in relevant scientific subject area, protein chemistry, analytical chemistry, lyophilisation, formulation, and the characterisation of the products along with a proven track record of having held a managerial/supervisory role in a laboratory setting. 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 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 careersmhra.gov.uk as soon as possible. Closing date: 01 December 2024 Shortlisting date: 02 December 2024 Interview date: 12 13 December 2024 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 careersmhra.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. 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 applicants 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 careersmhra.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 Mira Mepa, Head of Recruitment and Operations, Mira.Mepamhra.gov.uk. If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk infocsc.gov.uk Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ Feedback will only be provided if you attend an interview or assessment. Security Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks. Nationality requirements This job is broadly open to the following groups: UK nationals nationals of the Republic of Ireland nationals of Commonwealth countries who have the right to work in the UK nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window) nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS) individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020 Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service Further information on nationality requirements (opens in a new window) Working for the Civil Service The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants. We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window). The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria. The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy. Diversity and Inclusion The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window). Apply and further information Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records. Contact point for applicants Job contact : Name : Andreea Iftimia-Mander Email : Andreea.Iftimia-Mandermhra.gov.uk Recruitment team Email : Careersmhra.gov.uk Further information 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 contact the Resourcing Team at Careersmhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - infocsc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ Apply at advertiser's site Share this page Print Email Facebook Twitter LinkedIn GMail