About the job

Job summary

We are currently looking for a Senior Scientist to join our Standards Lifecycle function within the Science, Research & Innovation group.

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.  

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 Scientific Research and Innovation Group delivers public health impact and world-leading research innovation via an ambitious Science Strategy. 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 Standards Lifecycle function will produce 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 WHO International Standards in use around the world to assure the quality of biologicals. The Function is responsible for the WHO and other Reference Materials and develops them from research and prototype through to completed validated products including manufacture and distribution.

Job description

What’s the role?

The post-holder will be responsible for the development of WHO International Standards and Reference Reagents in the Immunology area, and for the associated research activities that underpin the standardisation programmes.

The role will support the improved understanding of structure-function relationships that impact efficacy, quality, and safety of biotherapeutic monoclonal antibodies, and harmonising efforts in the assessment of cellular immune responses, working closely with the Research and Development function to ensure the availability of appropriate assay methods and associated reference materials.

Key responsibilities: 

• Lead the end-to-end development of new and replacement WHO reference materials in the Immunology area. Oversee project approvals, source material, process development, planning and performance of lab-based evaluations, international collaborative study organisation, data collection, analysis and reporting, and maintenance of a project dossier in line with relevant internal and WHO Quality requirements.
• Contribute to the management of the Immunology reference materials portfolio, including sales monitoring, strategic decisions, and responding scientific enquiries.
• Maintain expertise and practical experience in a range of laboratory techniques to assess and characterize a broad range of biological medicines, including cell-based bioassays for therapeutic monoclonal antibodies (for target-associated and Fc-mediated functions) and various immunoassays and assay platforms to assess immune cell response and biomarkers (flow cytometry, ELISpot/FluoroSpot, ELISA). Includes working with primary cells, cell culture maintenance and cell banking.
• Contribute to Research & Development projects which underpin Standardisation activities, through provision of expertise in analytical laboratory techniques, as appropriate. Working under ISO 17025 and GCP compliance may be required.

Person specification

Our successful candidate will: 

• Have a PhD in a relevant scientific subject area (e.g. immunology, medical/clinical science, biological sciences) or equivalent experience
• Be organised and able to work on different concurrent projects working to a deadline, and able to focus on priorities and quality outcomes while working independently or as part of a team
• Have demonstrable knowledge and practical experience in a range of laboratory techniques used to assess biological activity of a broad range of biological medicines, including cell-based bioassays for therapeutic monoclonal antibodies, and immunoassays and assay platforms to assess cellular immune response and biomarkers
• Have thorough understanding of the importance and principles of biological standardisation ideally acquired through experience of developing reference materials and/or performing biological assays.
• Have strong project management skills, ideally applied to reference materials development and/or assay development

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! 

 

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Benefits

Alongside your salary of £42,869, Medicines and Healthcare Products Regulatory Agency contributes £11,574 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

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, along with a statement of suitability, attached as a PDF demonstrating how you meet the person specification. 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.
• 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.

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 and the statement of suitability provided. You can view the criteria for this role in the job description.

 

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: 29th February 2024

Shortlisting date: 11th March

Interview date: W/C 18th March 2024

 

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.

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 Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@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 

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.