Principal Scientist, Immunochemistry - £60,778 p.a. + benefits

Medicines and Healthcare products Regulatory Agency; Potters Bar; On-site; GBP 61,000; Full time

Job summary

A government regulatory agency in Potters Bar is looking for a scientific leader to manage a team focused on analytical techniques for biological medicines. Candidates should have extensive experience with ISO17025 and the ability to motivate staff. The role entails ensuring compliance, managing resources, and engaging stakeholders effectively. Offering a salary of £60,778 and enhanced benefits including flex time, staff development opportunities, and a generous pension plan.

Benefits

Civil Service Defined Benefit Pension

25-30 days annual leave

Flexible working hours

Employee Assistance Services

Qualifications

• Extensive experience in ISO17025 management system.
• Ability to motivate staff and respond to change.
• Experience with audit and inspection under quality management systems.

Responsibilities

• Ensure analytical assays comply with ISO17025.
• Manage delivery of improvements through resource organization.
• Engage with stakeholders to ensure quality service.

Skills

Experience within ISO17025 quality management system

Laboratory methods expertise (ELISA, immunodiffusion)

Analysing large complex data sets

Clear communication

Staff management and training

Education

PhD in a relevant field or equivalent experience

Tools

LIMS

Job description

This is a full‑time opportunity, on a permanent basis. The role will be based in South Mimms, Hertfordshire. The role can only be worked in the UK, not overseas. The role will provide expert scientific direction and line management to a team of analytical scientists focused on immunochemical assays used for the characterisation of biological medicines to deliver the Agency's independent control testing function. The Immunochemistry team will perform a range of analytical techniques including, but not limited to, ELISA‑based assays, immunodiffusion, immunoblotting and antibody‑based multiplex assays.

This is an exciting opportunity to apply scientific expertise and develop leadership and management skills to support the timely supply of safe and effective vaccines and blood products to patients. The postholder will also contribute to the strategic planning for the Control Testing function within the S&R Group.

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.

Required Experience and Technical Qualifications

• 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 and effectively respond to change.
• Engage with a wide variety of stakeholders, using clear communication to foster collaboration, deliver expert services, training, scientific and technical advice.
• Experience with audit and inspection under quality management systems, ideally ISO17025 and management of outcomes.
• Extensive experience of using a LIMS; analysing large complex data sets, including suitable statistical analysis.
• Experience of managing and training analytical staff.
• Expertise in one or more of the following: ELISA‑based assays, immunodiffusion, immunoblotting and antibody‑based multiplex assays.
• A PhD in a relevant field or extensive equivalent experience, together with significant experience in the analysis of biological medicines, including vaccines.

Nationality Requirements

• UK nationals
• Nationals of the Republic of Ireland
• Nationals of Commonwealth countries who have the right to work in the UK
• Nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre‑settled status under the EU Settlement Scheme (EUSS)
• Nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre‑settled status under the EU Settlement Scheme (EUSS)
• Individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

EEO Statement

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles. The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria. The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Security and Health Checks

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro‑life activism checks. People working with government assets must complete basic personnel security standard checks. Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance.

Benefits and Working Arrangements

• Salary: £60,778
• Medicines and Healthcare Products Regulatory Agency contributes £17,607 towards a member of the Civil Service Defined Benefit Pension scheme.
• Annual leave: 25 days on entry, rising to 30 days; 8 bank holidays
• Privilege leave: 1 day
• Hours of work: 37 hours (net) per week for full‑time staff
• Occupational Sick Pay: One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
• Flex time: flexible working to maintain a healthy work‑life balance
• Interest‑free season ticket loan or bike loan
• Employee Assistance Services and access to the Civil Service Benevolent Fund
• Eligibility to join the Civil Service Motoring Association (CSMA)
• Participation in staff and Civil Service clubs and ongoing learning and development