Senior Scientist - Molecular Assays

at  Medicines and Healthcare products Regulatory Agency

We are currently looking for a Senior Scientist – Molecular Assays to join our Control Testing team within the Science, Research & Innovation group.
This is a full-time opportunity, on a permanent basis. The role will be lab based in South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas.

WHO ARE WE LOOKING FOR?

Our successful candidate will:

• A relevant degree with experience of molecular analysis of biological medicines, including plasma pools, blood-derived products and/or vaccines.
• Advanced experience of working within ISO17025 (or other relevant) quality management system.
• Expert knowledge and experience in one or more of the laboratory methods listed in the job description with a proven track record in troubleshooting.
• Proven ability of working accurately and with attention to detail with experience of using a LIMS.
• Excellent team working and communication skills with good ability in planning and time management.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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THE SELECTION PROCESS:

We use the Civil Service Success Profiles to assess our candidates, find out more here.

• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the crtieria for this role in the job description.

WHAT’S THE ROLE?

The role will provide expert scientific support in a team of analytical scientists focused on molecular assays used for the characterisation of biological medicines as part of the Agency’s independent batch release function. The Molecular Assay team will perform a range of analytical techniques including, but not limited to, platform-based adventitious agent detection; PCR, q(RT)-PCR, ddPCR, nucleic acid sequencing and preparation of protein-based or complex mixture products for appropriate analysis.

KEY RESPONSIBILITIES:

• Use technical expertise in specific assays to provide training, mentor and supervise other team members, identifying issues and guiding resolutions, developing tests where required, providing advice to colleagues across the Agency to support the product lifecycle, including product research, biological standardisation, regulatory decisions, and adverse event investigations
• Use knowledge and experience of working within the ISO17025 (or other relevant) quality management system for assay development, validation and troubleshooting. Identify opportunities for service improvement.
• 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.
• 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.