Description We are currently looking for a Senior Scientist and Cell Production Lead to join our Biotherapeutics & Advanced Therapies team in the Research & Development 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 Science, Research & 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 4 sub-Groups, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety. The Research & Development function deliver statutory mandated strategically aligned, sustainable and impactful Regulatory Scientific research that is applied primarily to biological reference materials development and medicines control testing and areas of international and national priority for extant and future biological medicines. R&D host and nurture the current excellence in research into biologicals, biological reference materials, biological activity measurements, product quality testing and standardisation that is currently hosted by the National Institute for Biological Standards and Control (NIBSC). This is a statutory activity and includes international centres of excellence such as those working on polio, influenza and the UK Stem Cell Bank. The Advanced Therapies Team in the R&D function comprises a multi-disciplinary team of internationally respected scientists whose focus is on the regulatory research required to ensure safe and effective Advanced Therapy medicines are available to patients. What’s the role? The post holder shall provide scientific and technical input into the day-to-day banking, QC activities of the UKSCB and validation of equipment and processes. They will ensure that the work streams are completed to the agreed timelines and within the required quality framework. The work will be centered around the banking, characterisation and safety testing of human embryonic stem cells under the Human and Tissues Authority (HTA) for Human Use (Regulations 2007). The post-holder is also expected to deliver on internal and external cell supply under the ISO 9001 quality system and to Deputise for the Head of Cell Production. Key responsibilities: Ensure effective service delivery by carrying out banking and quality control testing of human embryonic stem cells according to UKSCB standard operating procedures and ensuring HTA compliance. Ensure effective delivery of cell production service under ISO9001, including banking, QC, stock control and supplying mammalian cells both globally and within the institute. Provide scientific and technical input into the banking programme including validation studies on processes and equipment. Write reports and represent the UKSCB at consortium and other meetings as appropriate. Deputise for the Head of Cell Production as required. Including, but not limited to: ensuring banks of cell lines are established according to documented procedures and specifications; Maintain Quality Systems operating in the Group (HTA and ISO 9001). Write, review and maintain quality records, including cell line documentation, qualification and validation reports, standard operating procedures, COSHH and risk assessments. Contribute to service delivery and improvement. Provide training in stem cell banking & QC procedures for staff, visiting workers and participants on UKSCB-run training courses. Monitor the effectiveness of UKSCB banking and identify areas of improvement and support implementation of new policies. Who are we looking for? Our successful candidate will meet the following criteria: BSc or MSc in cell or molecular biology, or a related discipline (or equivalent experience). Knowledge of working with under HTA (Human Application) and/or GMP. Extensive practical experience of pluripotent stem cell cultures and of other mammalian cell types. Extensive practical experience of molecular and cell biology, including microscopy, flow cytometry and qPCR. Delivering at Pace – Excellent organisational skills and ability to plan work to optimise time management and output across multiple projects. 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 careersmhra.gov.uk The selection process: We use the Civil Service Success Profiles to assess our candidates, find out more here. Online application form, including questions that assess the Behaviour, Experience and Technical criteria on 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. Previous applicants need not apply. 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 answers provided. You can view the criteria for this role in the job description. In the instance that we receive a high number of applications, we will first sift against the lead criteria of ‘Knowledge of working with under HTA (Human Application) and/or GMP.’ 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 careersmhra.gov.uk as soon as possible. Closing date: 31 January 2025 Shortlisting date: 3 – 7 February 2025 Interview date: 17 – 21 February 2025 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 careersmhra.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 careersmhra.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.Mepamhra.gov.uk. If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk infocsc.gov.uk Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ