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Head of Biotherapeutics and Advanced Therapies
1 month ago
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.
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Who are we?�
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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.
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What�s the role?
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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:�
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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:
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A 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 ( 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�
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If you would like to find out more about this fantastic opportunity, please read our�
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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. 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 ServiceFlexible 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�