Senior Scientist – Control Testing
Full‑time, permanent role based in South Mimms, Hertfordshire.
The Medicines and Healthcare products Regulatory Agency (MHRA) enhances and improves the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The Science and Research Group delivers public health impact, world‑leading research innovation, and a unique regulatory proposition for patients and users via an ambitious Science Strategy. The Control Testing team delivers the statutory function of independent control testing of biological medicines, including blood products and vaccines, helping to ensure patients have access to new and existing products.
What’s the role?
The role primarily facilitates the independent control testing of blood‑derived biological medicines and vaccines to deliver the Agency’s independent control testing function. The Separation Science team will perform a range of analytical techniques including HPLC based methods (reverse phase, size exclusion, ion exchange chromatographs with various detection modules), SDS‑PAGE, capillary electrophoresis and other product‑specific assays for the analysis of immunoglobulin and albumin products.
Key responsibilities
* Ensure analytical assays are performed in compliance with ISO17025, including assay development, validation and troubleshooting.
* Manage the day‑to‑day implementation and delivery of improvements in patient outcomes through organisation of resources, process improvement and changes in working practice, including training and innovative assay development.
* Advise and supervise training of staff in specific assays and administration of control testing.
* Engage with stakeholders, as required by the team lead, including colleagues across the Agency and other National Control Laboratories and manufacturers to ensure quality of service and patients’ access to medicines.
Who are we looking for?
* Extensive experience of working within an ISO17025 quality management system.
* Extensive experience of one or more of the laboratory methods listed in the job description.
* Extensive experience of using a LIMS.
* Ability to create a professional collaborative environment to motivate staff, be supportive and effective at managing change and implementing improvements.
* Ability to engage with a wide variety of stakeholders, using clear communication to foster collaboration, deliver expert services, training, scientific and technical advice.
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