Principal scientist, Cell-Based Assays - £60,778 p.a. + Benefits

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

Job summary

A leading health regulator in the UK seeks an expert to lead a team of analytical scientists in cell-based assays for biological medicines. This full-time role involves ensuring compliance with ISO17025, managing day-to-day improvements in outcomes, and engaging with various stakeholders. Candidates should have a strong background with ISO17025, LIMS, and specific laboratory techniques. Competitive salary of £60,778 alongside substantial benefits including a civil service pension. All applications must adhere to specific eligibility requirements.

Benefits

Generous annual leave entitlements

Occupational Sick Pay

Access to Employee Assistance Services

Flexible working options

Civil Service Pension Scheme

Qualifications

• Extensive experience of working within ISO17025 quality management system.
• Ability to create a collaborative environment to motivate staff.
• Engage with a wide variety of stakeholders.

Responsibilities

• Ensure analytical assays are performed in compliance with ISO17025.
• Manage the implementation of improvements in patient outcomes.
• Advise and supervise training of staff in specific assays.

Skills

Experience with ISO17025

Laboratory methods expertise

LIMS experience

Stakeholder engagement

Data analysis

Training and managing staff

Communication skills

Teamwork

Education

PhD in relevant field or equivalent experience

Tools

Analytical techniques (e.g., FACS, microscopy)

Job description

This is a full-time opportunity, on a permanent basis. The role will be based in South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas.

The role will provide expert scientific direction and line management to a team of analytical scientists focused on cell-based assays used for the characterisation of biological medicines to deliver the Agency's independent control testing function. The Cell-based assay team will perform a range of analytical techniques including, but not limited to fluorometric, microscopy, foci-forming assays, Fluorescence Activated Cell Sorting (FACS), plaque forming and plaque reduction neutralisation assays.

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.

Application Process

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.

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.

Nationalities and Eligibility

• UK nationals
• National of the Republic of Ireland
• National of Commonwealth countries who have the right to work in the UK
• National of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• National 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 European Union 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

Security and Health Surveillance

Applicants who are successful at interview will be, as part of pre‑employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant's details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Further information on nationality requirements.

Qualifications, Experience and Technical Criteria

• 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.
• Working Together (A, I)
• Communicating and Influencing (A, I)
• Experience with audit and inspection under quality management systems, ideally ISO17025 and management of outcomes. (A, I)
• Extensive experience of using a LIMS; analysing large complex data sets, including suitable statistical analysis. (A, I)
• Experience of managing and training analytical staff. (A, I)
• Expertise in one or more of the following: fluorometric, microscopy, foci‑forming assays, Fluorescence Activated Cell Sorting (FACS), plaque forming and plaque reduction neutralisation assays. (A, I)
• A PhD in a relevant field or extensive equivalent experience, together with significant experience in the analysis of biological medicines, including vaccines. (A)
• Team Player (I)
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

Benefits and Working Conditions

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro‑rata for part‑time staff. PLUS 8 bank holidays.
• Privilege Leave: 1 day.
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro‑rata for part‑time staff.
• Occupational Sick Pay (OSP): 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.
• Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service.
• Civil Service Pension Scheme.
• Flexible working to ensure staff 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).
• Variety of staff and Civil Service clubs.
• On‑going learning and development.

Diversity and Inclusion

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. The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan and the Civil Service Diversity and Inclusion Strategy.

Additional Information

The role sits within the Control Testing team in the Scientific Research function of the MHRA. 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.

Alongside your salary of £60,778, Medicines and Healthcare Products Regulatory Agency contributes £17,607 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard checks.