Higher Scientist, Cell Based Assays
We are currently looking for a Higher Scientist, Cell Based Assays to join our Control Testing Function within the Scientific Research and Innovation group.
This is a full-time opportunity, on a permanent basis. The role will be based in South Mimms, Hertfordshire.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
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 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 post is for a laboratory-based scientist who will be part of a team of analytical scientists focused on cell-based assays used for the characterisation of biological medicines as part of the Agency’s independent batch release function. The post holder will evaluate a wide range of vaccines and blood products. They will work under the ISO17025 quality standard to perform a range of assays, including but not limited to, colourimetric, microscopy, foci-forming assays, plaque forming and plaque reduction neutralisation assays.
This is an exciting opportunity to apply technical expertise and develop knowledge of regulatory science to ensure that patients have access to safe and effective vaccines and blood products.
Key responsibilities:
* Perform analytical assays in compliance with ISO17025, including assay development, validation, and troubleshooting.
* Coordinate with the scientists within the Control Testing teams to ensure the timetable of analysis and documentation of samples supplied for laboratory testing and data entry into a Laboratory Information Management System (LIMS) is achieved.
* Advise and supervise training of team members 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, to ensure quality of service and identify improvement and changes in working practices.
Who are we looking for?
Oursuccessful candidate will have:
* Experience of working in a laboratory.
* Experience of one or more of the laboratory methods listed in the job description.
* Excellent teamwork and communication skills.
* Good planning and time management skills.
* Ability to work accurately and with attention to detail.
Person Specification:
Method of assessment: A=Application, I=Interview
Behaviour Criteria:
* Working Together (A, I)
* Communicating and Influencing (A, I)
Experience Criteria:
* Experience of working accurately and precisely with an attention to detail typically achieved through working within ISO17025 quality management system, or similar, with experience of method validation, data management and monitoring, and data checks, entry and review (A, I)
* Experience of using a Laboratory Information Management System, with an understanding of statistical packages to analyse and present data and a good understanding of the use of a LIMS software package for accurate data capture, data analysis and review (A, I)
Technical Criteria:
* Expertise in the growth and manipulation of primary and continuous cell lines (derived from human, animal, etc) (A, I)
* Experience in one or more of the following: infectivity assays, plaque forming, plaque reduction neutralisation test, foci-forming assays (FFA), quantitative potency assay (QPA), microscopy (A, I)
* A degree in a relevant field, or equivalent experience together with experience in the cell-based analysis of biological samples, including vaccines (A)
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