Senior Scientist; InSPIREmed

Job Description

Senior Scientist (InSPIREmed) to join the Research & Development Function within the Scientific Research and Innovation group of the Medicines and Healthcare products Regulatory Agency. The role is full‑time on a fixed‑term contract until 30 April 2029, based in South Mimms, Hertfordshire.

The agency regulates medicines and medical devices to improve health outcomes. The SR&I R&D function delivers research on biological reference materials, quality testing and standardisation, supporting the development of future biological medicines.

The Senior Scientist will work hands‑on on the Integrated Spectroscopy and Photonics for Increased Productivity and Resource Efficiency in Medicines Manufacture (InSPIREmed) project. Responsibilities include coordinating freeze‑drying runs, developing spectroscopic Process Analytical Technology (PAT) systems, and performing conventional analysis of freeze‑dried products.

• Perform research and development activities related to formulation, freeze drying and relevant characterisation methods of biological materials for the InSPIREmed project.
• Provide hands‑on expertise of trial formulation and freeze‑drying conditions for standard biological materials.
• Have a working 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.

• Engage effectively with internal and external partners, contributing to collaborative scientific outputs and fostering a positive team culture.
• Strong familiarity and understanding in areas related to the development and characterisation of biological medicines.
• Experience of lyophilising biological medicines, formulation of products and optimisation of freeze‑drying cycles.
• Postgraduate qualification in a relevant scientific subject area, e.g., protein chemistry, analytical chemistry, biochemical engineering.
• Ability to communicate thoughts and ideas verbally or in writing, simplifying complexities and adapting communication so others can understand.
• Experience with analytical characterisation, including spectroscopic, of lyophilised biological medicines.