Senior Scientist (InSPIREmed) - £46,160-£51,666 p.a. + benefits

South Mimms, Hertfordshire

Job Summary We are currently looking for a Senior Scientist (InSPIREmed) to join our Research and Development Function within the Scientific Research and Innovation group.

This is a full-time opportunity, on a fixed term contract basis until 30th April 2029 . The role will be based in South Mimms, Hertfordshire.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

Job Description 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 Scientific Research and Innovation Group (SR&​I) 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 SR&​I Research &​ Development (R&​D) function will deliver statutory mandated strategically aligned, sustainable and impactful Regulatory Scientific research that is applied primarily to biological reference materials development and medicines control testing in areas of international and national priority for future biological medicines. Research and Development will host and nurture the current excellence in research into 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).

Analytical and Biological Sciences (ABS) is a multi-laboratory, multi-disciplinary team of experts within R&​D. Both in vitro and in vivo methods are used to deliver practical laboratory analysis, experimentation and expertise aligned with the Agency’s objectives. The Formulation Science team not only contribute to site-wide projects but also pursue their own research areas in collaboration with industrial and academic colleagues in their respective field. Their role is to develop suitable formulations and lyophilisation processing conditions and carry out supportive research in order to facilitate the reference material program of the SR&​I Group.

What’s the role? The Senior Scientist will have hands-on responsibility for delivering work related to the InSPIREmed project (Integrated Spectroscopy and Photonics for Increased Productivity and Resource Efficiency in Medicines Manufacture). The project brings together a consortium of world-leading organisations to develop a new generation of high-performance, integrated photonic Process Analytical Technology (PAT) systems. The Senior scientist will be responsible for coordinating pilot- and full-scale freeze-drying runs of model materials, allowing for the development of the spectroscopic PAT, as well as performing conventional pre- and post-analysis of the freeze-dried products.

Key Responsibilities:

• Perform research and development activities related to formulation, freeze drying and relevant characterisation methods of biological materials related to the goals of the InSPIREmed project.
• Provide hands on expertise of trial formulation and freeze-drying conditions for standard biological materials related to the InSPIREmed project.
• To have understanding, and possibly experience, of PAT (preferably spectroscopic) applied to pharmaceutical products, preferably biologics.
• Analyse complex datasets, interpret results, and generate evidence to inform reagent development and assay standardisation.
• Maintain strong relationships with global collaborators.

Who are we looking for? Our Successful Candidate Will Demonstrate:

• Ability to Work Together: Engage effectively with internal and external partners, contributing to collaborative scientific outputs and fostering a positive team culture.
• Strong familiarity/understanding in areas related to the development and characterization of biological medicines.
• Experience of lyophilising biological medicines, formulation of products and optimisation of freeze-drying cycles.
• Postgraduate qualification in relevant scientific subject area, for example protein chemistry, analytical chemistry, biochemical engineering.
• Ability to communicate thoughts and ideas, verbally or in writing. You simplify complexities and adapt communication so others can understand.5 civil service success profiles here excl. ability and strengths

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 Scientific Research and Innovation Group (SR&​I) 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 SR&​I Research &​ Development (R&​D) function will deliver statutory mandated strategically aligned, sustainable and impactful Regulatory Scientific research that is applied primarily to biological reference materials development and medicines control testing in areas of international and national priority for future biological medicines. Research and Development will host and nurture the current excellence in research into 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).

Analytical and Biological Sciences (ABS) is a multi-laboratory, multi-disciplinary team of experts within R&​D. Both in vitro and in vivo methods are used to deliver practical laboratory analysis, experimentation and expertise aligned with the Agency’s objectives. The Formulation Science team not only contribute to site-wide projects but also pursue their own research areas in collaboration with industrial and academic colleagues in their respective field. Their role is to develop suitable formulations and lyophilisation processing conditions and carry out supportive research in order to facilitate the reference material program of the SR&​I Group.

What’s the role? The Senior Scientist will have hands-on responsibility for delivering work related to the InSPIREmed project (Integrated Spectroscopy and Photonics for Increased Productivity and Resource Efficiency in Medicines Manufacture). The project brings together a consortium of world-leading organisations to develop a new generation of high-performance, integrated photonic Process Analytical Technology (PAT) systems. The Senior scientist will be responsible for coordinating pilot- and full-scale freeze-drying runs of model materials, allowing for the development of the spectroscopic PAT, as well as performing conventional pre- and post-analysis of the freeze-dried products.

Our Successful Candidate Will Demonstrate:

• Ability to Work Together: Engage effectively with internal and external partners, contributing to collaborative scientific outputs and fostering a positive team culture.
• Strong familiarity/understanding in areas related to the development and characterization of biological medicines.
• Experience of lyophilising biological medicines, formulation of products and optimisation of freeze-drying cycles.
• Postgraduate qualification in relevant scientific subject area, for example protein chemistry, analytical chemistry, biochemical engineering.
• Ability to communicate thoughts and ideas, verbally or in writing. You simplify complexities and adapt communication so others can understand.5 civil service success profiles here excl. ability and strengths

Person specification

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria:

• Delivering at Pace (A, I)
• Working Together (A, I)

Experience Criteria:

• Strong familiarity/understanding in areas related to the development and characterization of biological medicines (A, I)
• Experience with Analytical characterisation, including spectroscopic, of lyophilised biological medicines (A, I)
• Experience of lyophilising biological medicines, formulation of products and optimisation of freeze-drying cycles (A, I)

Technical Criteria:

• Postgraduate qualification in relevant scientific subject area, for example protein chemistry, analytical chemistry, biochemical engineering

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.uk Alongside 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 (opens in a new window).

• 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 Wor