About the job

Job summary

We are currently looking for a Head of Biotherapeutics & Advanced Therapies to join our Research & Development function within the Science, Research & Innovation group.

This is a full-time opportunity, on a fixed term contract/internal move or temporary promotion basis until 31st March 2025. 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 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 Research & Development function focuses on the development of biological reference materials and assays within regulatory sciences, as well as R&D activities in areas of international and national priority for extant and future biological medicines and innovative therapies, diagnostics, and vaccines.

 

What’s the role?

 

The role will provide strategic scientific leadership and management of expert scientists that address distinct aspects of regulatory scientific research into the areas of Biotherapeutics and Advanced Therapies. These include Advanced Therapies Medicinal Products (ATMPs), such as cell and gene therapy products and pluripotent stem cell-based medicines as well as monoclonal antibodies, immunotherapies and protein-based biotherapeutics. The role will oversee Research and Development as well as influence the development of new physical standards and reference materials that underpin these important products.

Job description

Key responsibilities: 

 

• Devise and direct an internationally recognised programme of R&D that addresses key regulatory scientific questions pertaining to Biotherapeutics and Advanced Therapies, with a specific focus on Cell and Gene Therapies, immunotherapies and monoclonal antibodies, which results in scientific data that has impact on the patient, supports the standardisation of novel therapies, is publishable in high quality scientific journals and attracts sustained external grant funding.
• Collaborate with colleagues in Standards Lifecycle and Control Testing Functions of SR&I to provide expert scientific advice and practical support for the timely production of physical standards and optimal control testing for Biotherapeutics and Advanced Therapies, where applicable.
• Represent the Agency externally as an expert in regulation and control of Biotherapeutics and Advanced Therapies, and provide state of the art guidance to senior colleagues and external organisations including, but not limited to, UK healthcare organisations, the World Health Organisation (WHO), the global pharmacopeia, EDQM, industry and academia; to establish and lead national and international collaborative work activities.
• As an active member of the R&D Senior Leadership Team, work closely with expert Agency colleagues across all groups to provide expert scientific advice relating to products within the biotherapeutics and advanced therapies area.

 

Person specification

Our successful candidate will have:

 

• A Ph.D. in Biomedical Science or related discipline, with extensive post-doctoral experience

 

• Internationally recognised expertise and a competitive track record in Biotherapeutics and/or Advanced Therapies, with proven experience of securing resources and successfully managing and delivering scientific projects

 

• In depth experience in practical aspects of biotherapeutics and/or advanced therapies products (e.g. cell and molecular biology, genetics, genomics, biological medicines standardisation)

 

• Familiarity and knowledge of the UK and European regulatory framework and environment as it related to biological medicines

 

• Ability to take a strategic perspective to identifying the capability needs of the organisation with the capability and experience to build a strong culture of continuous learning and knowledge sharing

 

 

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 

Benefits

Alongside your salary of £75,000, Medicines and Healthcare Products Regulatory Agency contributes £20,250 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 a statement of suitability, attached as a PDF of no more than 1000 words 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.
• 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 statement of suitability provided. You can view the criteria 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: 12th August 2024

Shortlisting date: 15th August 2024

Interview date: W/C 26th August 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 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.