Head of Formulation Science - £73,324 - £80,000 p.a. + benefits
Join to apply for the Head of Formulation Science - £73,324 - £80,000 p.a. + benefits role at Medicines and Healthcare products Regulatory Agency
Head of Formulation Science - £73,324 - £80,000 p.a. + benefits
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Join to apply for the Head of Formulation Science - £73,324 - £80,000 p.a. + benefits role at Medicines and Healthcare products Regulatory Agency
Job Summary
We are currently looking for a
South Mimms, Hertfordshire
Job Summary
We are currently looking for a Head of Formulation Science to join our Science, Research & Innovation group.
This is a full-time opportunity, on a permanent basis. The role will be based lab based in South Mimms, Hertfordshire.
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 agency is made up of c.1600 staff working across two main centres and peripatetically across the UK and abroad. The agency consists of Scientific Research & Innovation, Healthcare Quality & Access, Safety & Surveillance, Corporate, Partnerships, Transformation, Governance, Communications & Engagement, and Digital & Technology groups. For more information on MHRA please click here.
Job Description
The Head of Formulation Science will provide scientific leadership and expertise in the formulation and stabilisation of biological reference materials. This role is critical in supporting the development of international standards that serve as the foundation for the safety and efficacy of biologics. The successful candidate will lead a team of experts focused on lyophilisation and physicochemical characterisation, ensuring the development of robust and stable freeze-dried reference materials for global standardisation efforts.
As a key figure within the Analytical and Biological Sciences Division, you will collaborate closely with internal and external partners, including international regulatory bodies, research institutions, and industry leaders. Your expertise will contribute to the formulation and characterisation of biological medicines, advancing the science that underpins regulatory decision-making.
Key Responsibilities And Results Areas
The role provides expertise & research capability in the area of biologics stabilisation and formulation.
The role holder will act as the Principal Scientist and the key responsibilities for the role are:
Leadership And Management:
* 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&I’s and the Agency’s goals.
* Provide expert advice and subsequent implementation of trial formulation and freeze-drying
conditions for all biological standards prepared at MHRA’s Science Campus requiring
lyophilization.
Service Delivery:
* Direct / maintain an Internationally recognised research program related to freeze-drying and
formulation of biologicals.
* Promote the MHRA’s 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.
* Identify opportunities for commercialization as well as secure and manage income from grants
and contract activities.
* Interact closely with the of Heads of Vaccine and Therapeutic Reference Materials 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.
* Through membership of internal boards provide specific expertise to the benefit of the whole
organisation.
Quality And Assurance:
* Manage section in accordance with ISO standards (ISO 9001).
* Manage generation and maintenance of associated documentation (e.g. Standard Operating
Procedures (SOPs), Design Dossiers) and those related to Health and Safety (e.g. risk
assessments) in compliance with the Agency’s policies.
The Head of Formulation Science will provide scientific leadership and expertise in the formulation and stabilisation of biological reference materials. This role is critical in supporting the development of international standards that serve as the foundation for the safety and efficacy of biologics. The successful candidate will lead a team of experts focused on lyophilisation and physicochemical characterisation, ensuring the development of robust and stable freeze-dried reference materials for global standardisation efforts.
As a key figure within the Analytical and Biological Sciences Division, you will collaborate closely with internal and external partners, including international regulatory bodies, research institutions, and industry leaders. Your expertise will contribute to the formulation and characterisation of biological medicines, advancing the science that underpins regulatory decision-making.
Quality And Assurance:
* Manage section in accordance with ISO standards (ISO 9001).
* Manage generation and maintenance of associated documentation (e.g. Standard Operating
Procedures (SOPs), Design Dossiers) and those related to Health and Safety (e.g. risk
assessments) in compliance with the Agency’s policies.
Person specification
Our Successful Candidate Will Have:
* 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.
* Project management knowledge. Prince 2 qualified to practitioner level or equivalent experience is desirable.
* Thorough understanding of the development process and role of International Standards and reference materials and wider metrology issues with the quantitation of biological medicines.
* 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.
* Proven track record of maintaining and developing research programs and active research collaborations with other researchers nationally and worldwide to seek and implement research grant funding for such research.
If you would like to find out more about this fantastic opportunity, and review the full Person Specification for this role, please read the Candidate Job Pack.
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
Selection process details
Application
This campaign is being run by Allen Lane Recruitment on behalf of MHRA. To apply for this post, you need to submit your application later than 9:00am on Monday 23rd June, providing the three documents outlined below and sending to MHRA@allenlane.co.uk.
* A CV setting out your career history, with key responsibilities and achievements. Please ensure you have provided reasons for any gaps within the last two years;
* A Statement of Suitability (no longer 1,250 words) explaining how you consider your personal skills, qualities and experience provide evidence of your suitability for the role, with particular reference to the criteria and Success Profiles in the person specification.
* A Diversity Monitoring Form. If you do not wish to provide a declaration on any of the particular characteristics, you will have the option to select ‘prefer not to say’. All monitoring data will be treated in the strictest confidence and will not be provided to the selection panel. The information you provide when submitting your application will help us monitor our progress towards the Civil Service becoming the most inclusive employer. Please see the candidate pack for details.
Interview and Presentation
You will be asked to attend a panel interview in order to have a more in-depth discussion of your previous experience and professional competence in relation to the criteria set out in the Person Specification that is in the candidate pack. The interview panel will include a 10-minute presentation – candidates will be given the topic in advance to allow for preparation ahead of the interview. All interviews will be conducted in person at the MHRA’s South Mimms location. The interview day will also include a lab visit.
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.
Closing date: 23rd June 2025 at 9:00am
Shortlisting date: Friday 4th July 2025
Interview date: W/C 7th July 2025
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 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
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.
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.
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).
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 : Ed Stroud
* Email : edstroud@allenlane.co.uk
Recruitment team
* Email : careers@mhra.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 Careers@mhra.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 - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Government Administration
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