Job Description
We are currently looking for a Senior Scientist to join our Control Testing Function within the Science and Research group. This is a full‑time, permanent role based in South Mimms, Hertfordshire.
What’s the role?
The role primarily facilitates the independent control testing of blood‑derived biological medicines and vaccines. The team performs a range of analytical techniques including, but not limited to, HPLC–based methods (reverse phase, sizing exclusion, ion exchange chromatograph), SDS‑PAGE, capillary electrophoresis and product‑specific assays for 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 resource organisation, 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, to ensure quality of service and patients’ access to medicines.
Our Successful Candidate Will Have
* Extensive experience of working within 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.
Person Specification
Behaviour Criteria
* Managing a Quality Service (Assessment, Interview)
* Working Together (Assessment, Interview)
* Delivering at Pace (Assessment, Interview)
Experience Criteria
* Advanced knowledge of ISO17025 (or other relevant) quality management systems including method validation, internal data monitoring and change control; experience as a Quality Coordinator or Internal Auditor is desirable (Assessment, Interview).
* Extensive experience of using a Laboratory Information Management System; advanced or superuser level experience is desirable (Assessment, Interview).
* Extensive experience with statistical analysis and interpreting results derived from large complex data sets (Assessment, Interview).
Technical Criteria
* Essential: Highly skilled in one or more of the following: HPLC‑based methods, SDS‑PAGE and capillary electrophoresis including problem‑solving and assay improvement (Assessment, Interview).
* Desirable: Advanced expertise in a range of HPLC methods including reverse phase, sizing exclusion and ion exchange chromatography (Assessment, Interview).
* PhD in a relevant field or extensive equivalent experience, together with significant experience in the analysis of biological medicines including at least one of the following sample types: proteins, immunoglobulins, vaccines or blood‑derived products (Assessment).
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