Medicines and Healthcare products Regulatory Agency

Gene Therapy Senior Scientist - £46,160 p.a. + benefits

Posted: 22 minutes ago

Job Description

South Mimms, HertfordshireJob SummaryWe are currently looking for a Gene Therapy Senior Scientist to join our Gene Therapy Function within the Science Research and Innovation group.This is a full-time opportunity, on a 12-month fixed term contract 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.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 research and development function of the MHRA Science Campus comprises a multi-disciplinary team of internationally respected scientists who deliver strategically aligned regulatory scientific research focused on the development and distribution of biological reference materials.The Gene Therapy team aims to impact the future safety and quality of gene therapies through addressing regulatory focused research questions and by driving the global harmonisation of gene therapy critical quality attribute assessment, underpinned by the development and application of new physical standards.Job DescriptionThe post will provide a practical lead in the development and delivery of high quality research and standardisation projects focused on the development of international standards and assays that will underpin national and international safety for these products. The work will be centred around viral vectors, with a particular focus on AAVs and Lentiviral vectorsus, CAR-T cell therapies and genome editing. The post holder is also expected to keep up to date with knowledge in other gene therapy areas and engage with colleagues across the agency to help bring gene therapy products to patients.Key Responsibilities:Contribute to the strategic direction of the design and development of novel gene therapy standards and assay developmentAssist in the delivery of gene therapy regulatory focused research activities using a collaborative approachOptimise and establish molecular, genetic, immunochemical, virological and cellular assays for the validation of viral vector standards and for the quality and safety control of gene therapy products.Gather, analyse and effectively present information to colleagues and collaborators. Use specialist tools as required for data generation and analysis, progress monitoring, material validation and report preparation.Take responsibility for laboratory facilities and equipment and provide supervision and training to junior team members where required.Provide support to colleagues in the Standards Lifecycle and Control Testing functions to ensure the timely production of physical standards and optimal control testing for biotherapeutic medicines.Engage with, national and international stakeholders and represent the agency externally where required.Who are we looking for?Our successful candidate will demonstrate the following.PhD in a gene therapy or molecular biology related discipline with relevant practical experience (or equivalent industry-based experience) and good understanding of the gene therapy field.Experience working in gene therapy research and developmentExtensive practical experience in viral vector production, handling and manipulation of mammalian cell lines, genome editing, primary cell culture and multi parameter flow cytometry.Extensive experience in molecular biology techniques such as q-PCR, d-PCR, ELISA and cloning.Experience in analysing information, including complex scientific data, to inform decisions and direct projects.Ability to work independently, monitor individual work milestones, manage multiple tasks, and prioritise workload accordingly. Demonstrate ability to work cooperatively as part of a wider multidisciplinary team, establishing professional collaborative relationships and sharing information and resourcesDelivery of high-quality outcomes on budget, identifying risks and aiming to resolve issues efficiently.The post will provide a practical lead in the development and delivery of high quality research and standardisation projects focused on the development of international standards and assays that will underpin national and international safety for these products. The work will be centred around viral vectors, with a particular focus on AAVs and Lentiviral vectorsus, CAR-T cell therapies and genome editing. The post holder is also expected to keep up to date with knowledge in other gene therapy areas and engage with colleagues across the agency to help bring gene therapy products to patients.Key Responsibilities:Contribute to the strategic direction of the design and development of novel gene therapy standards and assay developmentAssist in the delivery of gene therapy regulatory focused research activities using a collaborative approachOptimise and establish molecular, genetic, immunochemical, virological and cellular assays for the validation of viral vector standards and for the quality and safety control of gene therapy products.Gather, analyse and effectively present information to colleagues and collaborators. Use specialist tools as required for data generation and analysis, progress monitoring, material validation and report preparation.Take responsibility for laboratory facilities and equipment and provide supervision and training to junior team members where required.Provide support to colleagues in the Standards Lifecycle and Control Testing functions to ensure the timely production of physical standards and optimal control testing for biotherapeutic medicines.Engage with, national and international stakeholders and represent the agency externally where required.Who are we looking for?Our successful candidate will demonstrate the following.PhD in a gene therapy or molecular biology related discipline with relevant practical experience (or equivalent industry-based experience) and good understanding of the gene therapy field.Experience working in gene therapy research and developmentExtensive practical experience in viral vector production, handling and manipulation of mammalian cell lines, genome editing, primary cell culture and multi parameter flow cytometry.Extensive experience in molecular biology techniques such as q-PCR, d-PCR, ELISA and cloning.Experience in analysing information, including complex scientific data, to inform decisions and direct projects.Ability to work independently, monitor individual work milestones, manage multiple tasks, and prioritise workload accordingly. Demonstrate ability to work cooperatively as part of a wider multidisciplinary team, establishing professional collaborative relationships and sharing information and resourcesDelivery of high-quality outcomes on budget, identifying risks and aiming to resolve issues efficiently.Person specificationMethod of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria: Delivering at Pace (I) Working Together (A, I) Managing a Quality Service (I)Experience Criteria: PhD in a gene therapy or molecular biology related discipline with relevant practical experience (or equivalent industry-based experience) and good understanding of the gene therapy field. (A, I) Experience working in gene therapy research and development (A, I, P) Experience or interest in standardisation and medicines control (A, I)Technical Criteria: Extensive practical experience in viral vector production, handling and manipulation of mammalian cell lines, genome editing, primary cell culture and multi parameter flow cytometry (A, I, P) Extensive experience in molecular biology techniques such as q-PCR, d-PCR, ELISA and cloning. (A, I, P)Strengths Criteria Analytical (I) Team Player (I)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.ukAlongside your salary of £46,160, Medicines and Healthcare Products Regulatory Agency contributes £13,372 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 ServiceCivil 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 detailsWe 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 candidates demonstrating In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of candidates demonstrating that they have experience or interest in standardisation and medicines control.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.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: 5th December 2025Shortlisting date: from 8th December 2025Interview date: from 17th December 2025If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.ukCandidates 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 Oleylami, 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.ukinfo@csc.gov.ukCivil Service CommissionRoom G/81 Horse Guards RoadLondonSW1A 2HQFeedback will only be provided if you attend an interview or assessment.SecuritySuccessful 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 requirementsThis Job Is Broadly Open To The Following Groups:UK nationalsnationals of the Republic of Irelandnationals of Commonwealth countries who have the right to work in the UKnationals 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 2020Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil ServiceFurther information on nationality requirements (opens in a new window)Working for the Civil ServiceThe 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 InclusionThe 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 applicantsJob Contact :Name : Claire KerridgeEmail : Claire.kerridge@mhra.gov.ukRecruitment teamEmail : Careers@mhra.gov.ukFurther informationIn 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

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