Head of Gene Therapy
Posted 2 days 6 hours ago by Medicines and Healthcare products Regulatory Agency
£125,000 - £150,000 Annual
Permanent
Full Time
Laboratory Jobs
England, United Kingdom
Job Description
We are currently looking for a Head of Gene Therapy to join our Biotherapeutics and Advanced Therapies Function within the Research and Development group.
This is a full-time opportunity, on a fixed term contract basis until 19th February 2027. The role will be 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 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.
What's the role? This post has the global role of developing and executing a programme of research & development for the standardisation and safety of gene therapy medicines. The post-holder is expected to deliver on existing projects, to actively contribute to other ongoing gene therapy projects across the group and to support the development of new projects through applications for externally funded research projects.
The role will lead a team of expert scientists to address prioritised regulatory scientific research focused on the safety, characterisation and accelerated regulatory approval of gene therapy medicines.
The role will establish and foster strategically important National and International research collaborations and will also liaise closely with scientists in Standards Lifecycle and Control Testing Functions as well as licensing colleagues in HQA and Safety and Surveillance Divisions. Aligned to effective communication and collaboration, the postholder will apply their highly specialist scientific knowledge in gene therapy products to improve efficiencies and optimise Agency activities to bring new and innovative medicines to UK patients.
Key responsibilities:
Behaviour Criteria:
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 .
The selection process: We use the Civil Service Success Profiles to assess our candidates, find out more here.
Use of AI in Job Applications Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see candidate guidance for more information on appropriate and inappropriate use.
If you require any disability related adjustments at any point during the process, please contact as soon as possible. Closing date: 26th January
Shortlisting date: from 2nd February
Interview date: from 16th February
If you need assistance applying for this role or have any other questions, please contact .
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.
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 . click apply for full job details
This is a full-time opportunity, on a fixed term contract basis until 19th February 2027. The role will be 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 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.
What's the role? This post has the global role of developing and executing a programme of research & development for the standardisation and safety of gene therapy medicines. The post-holder is expected to deliver on existing projects, to actively contribute to other ongoing gene therapy projects across the group and to support the development of new projects through applications for externally funded research projects.
The role will lead a team of expert scientists to address prioritised regulatory scientific research focused on the safety, characterisation and accelerated regulatory approval of gene therapy medicines.
The role will establish and foster strategically important National and International research collaborations and will also liaise closely with scientists in Standards Lifecycle and Control Testing Functions as well as licensing colleagues in HQA and Safety and Surveillance Divisions. Aligned to effective communication and collaboration, the postholder will apply their highly specialist scientific knowledge in gene therapy products to improve efficiencies and optimise Agency activities to bring new and innovative medicines to UK patients.
Key responsibilities:
- Contribute to the development of a research portfolio of projects related to the standardisation and safety of gene therapy medicines and build up capability and resilience in future gene therapy standardisation area.
- Initiate and drive gene therapy research activities, which result in scientific data that is publishable in high quality scientific journals and attracts sustained external grant funding. Identify potential sources of income generation and apply for external grant funding for specialist projects.
- Assure that project deliverables and internal objectives are met. Undertake general project administration for the projects, including financial monitoring and reporting. Monitor the effectiveness of the activities, identify areas of improvement and support implementation of new policies.
- Maintain and disseminate up-to-date knowledge around gene therapy research and standardisation. Work with the national and international gene therapy community to develop and disseminate good practices. Represent the Group and the Agency at national and international conferences and other relevant meetings/workgroups as appropriate.
- Work within the required quality framework (e.g. ISO 13485, ISO 34). Write, review and maintain quality records, including the generation of production records and reports, standard operating procedures, COSHH and risk assessments.
- Work closely and communicate effectively with Agency colleagues as required (including Standards Lifecycle, British Pharmacopeia and Licensing) to provide expert scientific advice and practical support as well as with external collaborators.
- PhD in molecular biology, virology, genetics or immunology, with strong and relevant post-doctoral experience.
- Extensive experience in gene therapy, molecular biology, virology, genetics and immunology.
- Experience or interest in standardisation, medicines control and working under a Quality Management System.
- Experience in developing and applying innovative technical procedures for product potency and efficacy quality control.
- Internationally competitive track record in gene therapy research and development and experience of securing resources.
Behaviour Criteria:
- Delivering at Pace (A, I)
- Working Together (A, I)
- Communicating and Influencing (I)
- Extensive experience in gene therapy, molecular biology, virology, genetics, and immunology (A, I, P)
- Experience in developing and applying innovative technical procedures for product potency and efficacy quality control (I, P)
- Internationally competitive track record in gene therapy research and development and experience of securing resources (A)
- Experience or interest in standardisation and medicines control and in working under a Quality Management System (A, I)
- In-depth practical experience in a broad range of relevant biological laboratory techniques, including cell culture and molecular biology (I, P)
- PhD in molecular biology, virology, genetics or immunology, with strong and relevant post-doctoral experience (A, I, P)
- Analytical (I)
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 .
The selection process: 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.
Use of AI in Job Applications Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see candidate guidance for more information on appropriate and inappropriate use.
If you require any disability related adjustments at any point during the process, please contact as soon as possible. Closing date: 26th January
Shortlisting date: from 2nd February
Interview date: from 16th February
If you need assistance applying for this role or have any other questions, please contact .
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.
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 . click apply for full job details