Healthcare Scientist

Job summary

The IVD Programme covers the regulation, management and governance of in-vitro diagnostic medical devices (IVDs) used for patient management within Public Health Microbiology (PHM) Directorate. Both in-house and commercial IVDs are included in its remit. The aim of the programme is to migrate all IVDs into regulatory compliance.

The Regulatory Assurance and Compliance Unit (RACU) has responsibility for review and update of standards, guidelines, and templates; manages the device proposal and authorisation system; reviews IVD validation documents; has oversight of surveillance systems; and maintains a register of IVDs used. The RACU acts as a focal point for communications with the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

The regulations are currently in transition from The Medical Devices Regulations 2002 to GB specific regulations informed by the Medicines and Medical Devices Act 2021. MHRA have advised to continue to use the EU IVDR as a guide while awaiting final confirmation of the GB regulations. Best practice oversight is also within the RACU remit, covering non-IVD assays such as UKHSA R&D and surveillance assays, so as to meet comparable standards to those for IVDs.

Working for your organisation

We pride ourselves as being an employer of choice, where Everyone Matters promoting equality of opportunity to actively encourage applications from everyone, including groups currently underrepresented in our workforce.

UKHSA ethos is to be an inclusive organisation for all our staff and stakeholders. To create, nurture and sustain an inclusive culture, where differences drive innovative solutions to meet the needs of our workforce and wider communities. We do this through celebrating and protecting differences by removing barriers and promoting equity and equality of opportunity for all.

Please visit our careers site for more information https://gov.uk/ukhsa/careers

Job description

• Lead on the scientific support for IVD governance
• Provide technical expertise to RACU
• Provide scientific advice and guidance and make recommendations to laboratory directors and departmental managers in achieving and maintaining IVD governance, working specifically as part of the IVD Compliance Project to ensure compliance with regulatory standards & in accordance with UKHSA policies and procedures

The above and below lists are only an outline of the tasks, responsibilities and outcomes required of the role. The post holder may carry out any other duties as may reasonably be required. The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation

• Support RACU in migrating PHM to compliance for in-house and commercial IVDs
• Project manage validation and verification assessments, in collaboration with RACU and PHM Lab departments
• Play a leading role in the assessment of new technologies and diagnostic tests to enhance the laboratories capabilities and ensure that the high scientific standards are followed
• Work independently and with the RACU Operations team to generate outputs to agreed timescales
• Familiarisation with IVD Regulations, maintaining awareness of updates where applicable
• Work with RACU to streamline and deploy existing cross laboratory validation documents as a manageable number of clear templates to comply with regulatory and MHRA guidelines, and existing or new guidelines from UKAS. Maintain awareness of relevant IVD standards (e.g. standard operating procedures, UK Standards for Microbiology Investigations) and perform gap analyses
• Inform the MHRA, where device performance or safety matters are considered to conflict with the manufacturer’s claims for intended use and/or CE or UKCA Marking status
• Advise and direct laboratory staff to comply with all relevant standards
• Suggest improvements and act on team improvement suggestions where necessary
• Liaise closely with laboratory and quality managers to ensure they are aware of IVD-related activities and issues in their departments
• Represent the RACU Operations Team at relevant meetings and seminars as necessary, undergo any training requirements as required for the post
• Maintain high professional standards by continual professional development keeping up to date with advances in medical microbiology
• Maintain a positive attitude to the work of the RACU Operations Team and related personnel
• Identify to management any potential conflicts of interest which may impinge on their ability to perform their duties effectively as defined by UKHSA Conflict of Interest Policy
• Ensure health, safety and welfare are afforded priority and demonstrate commitment to health, safety and welfare of self, staff and visitors and comply with relevant UKHSA health and safety policies at all times

Person specification

Essential Criteria:

• Science degree or equivalent in microbiology or a related pathology discipline
• Postgraduate scientific qualification or demonstrable equivalent experiential learning gained in a medical laboratory environment, alongside evidence of continuing professional development
• Knowledge and experience of IVD validations/verifications
• Substantial recent experience working in an accredited clinical diagnostic or reference virology or bacteriology and;
• Knowledge of IVD regulations (e.g. IVDR) and experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories
• Understanding and experience of change management
• Good knowledge and experience of serological methods including ELISA and IFA; and of molecular diagnostics methods including but not limited to NAATs, PCR, sequence analysis, whole genome – and/or next generation genome – sequencing
• Experience of leading and managing projects
• Excellent verbal and written communication, including experience of writing and preparing reports for senior management, data analysis and statistical skills
• Experience of attending management meetings and presenting information to management.
• Ability to work on own initiative and as part of a team
• Excellent interpersonal, negotiating and organisational skills, self-motivated, analytical and adaptable

Desirable Criteria

• Wide experience of common office software applications, using and setting up databases, e.g. Jira
• Knowledge of GxP & safety requirements

Benefits

Alongside your salary of £41,983, UK Health Security Agency contributes £12,162 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension with an employer contribution of 28.97%

Things you need to know

Artificial intelligence

Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

This vacancy is using Success Profiles and will assess your Behaviours, Experience and Technical skills.

Stage 1: Application & Sift

You will be required to complete an application form. You will be assessed on the listed 12 essential criteria, and this will be in the form of a:

• Application form (‘Employer/ Activity history’ section on the application)
• 1500 word supporting statement.

This should outline how you consider your skills, experience and knowledge provide evidence of your suitability for the role, with reference to the essential criteria.

You will receive a joint score for your application form and statement. (The application form is the kind of information you would put into your C.V –please be advised you will not be able to upload your CV. Please complete the application form in as much detail as possible). Please do not email us your CV.

Longlisting:

In the event of a large number of applications we will longlist into 3 piles of:

1. Meets all essential criteria
2. Meets some essential criteria
3. Meets no essential criteria

If used, the piles ‘Meets all essential criteria’ and ‘Meets some essential criteria’ will proceed to shortlisting.

Shortlisting:

In the event of a large number of applications we may conduct an initial sift, on the lead criteria of:

• Postgraduate scientific qualification or demonstrable equivalent experiential learning gained in a medical laboratory environment, alongside evidence of continuing professional development
• Substantial recent experience working in an accredited clinical diagnostic or reference virology or bacteriology
• Knowledge of IVD regulations (e.g. IVDR) and experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories

If you are successful at this stage, you will progress to interview.

Feedback will not be provided at this stage.

Stage 2: Interview

You will be invited to a single remote interview.

Behaviours and Technical skills will be tested at interview.

The Behaviours tested during the interview stage will be:

• Making Effective Decisions (Lead behaviour)
• Communication and Influencing
• Managing a Quality Service

Technical Skills will be assessed via technical based questions.

Interviews dates to be confirmed.

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Location

This role is being offered as hybrid working based at any of our Core HQ’s or at our Scientific Campus in either London (Colindale) or Porton.

We offer great flexible working opportunities at UKHSA and operate using a hybrid working model where business needs allow. This provides us with greater flexibility about how and where we work, to get the best from our workforce. As a hybrid worker, you will be expected to spend a minimum of 60% of your contractual working hours (approximately 3 days a week pro rata, (averaged over a month) working at one of UKHSA's core HQ’s (Birmingham, Leeds, Liverpool, and London) or at one of our scientific campus sites (Colindale, Porton). Our core HQ offices are modern and newly refurbished with excellent city centre transport link and benefit from benefit from co-location with other government departments such as the Department for Health and Social Care (DHSC).

If based at one of our scientific campuses, you will be required to have a minimum of a Counter Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC) clearance. In exceptional circumstances UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder/Recruiting Manager listed in the advert for further advice.

Security Clearance Level Requirement

Successful candidates must pass a standard disclosure and barring security check.

Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Baseline Personnel Security Standard or Counter Terrorism Check. This will be dependant on your chosen office location.

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including internal applicants).

Future location

UKHSA is investing in a new state-of-the-art National Biosecurity Centre in Harlow, Essex, which will eventually bring together teams currently based at Canary Wharf, Colindale and Porton Down. For more details, please see: Huge biosecurity centre investment to boost pandemic protection - GOV.UK.

The new facilities will start becoming operational in the mid-2030s, with full completion by 2038. Staff will move in phases as facilities become available. If you're appointed to a role currently based at Canary Wharf, Colindale or Porton Down, please note that we'll continue investing in these sites for the next decade. As we get closer to the transition, we'll provide full information about relocation support available to staff.

Reasonable Adjustments

The Civil Service is committed to making sure that our selection methods are fair to everyone. To help you during the recruitment process, we will consider any reasonable adjustments that could help you. An adjustment is a change to the recruitment process or an adjustment at work. This is separate to the Disability Confident Scheme. If you need an adjustment to be made at any point during the recruitment process you should contact the recruitment team in confidence as soon as possible to discuss your needs.

You can find out more information about reasonable adjustments across the Civil Service here: https://www.civil-service-careers.gov.uk/reasonable-adjustments/

International Police check

If you have spent more than 6 months abroad over the last 3 years you may need an International Police Check. This would not necessarily have to be in a single block, and it could be time accrued over that period.

Internal Fraud check

If successful for this role as one aspect of pre-employment screening, applicant’s personal details – name, national insurance number and date of birth - will be checked against the Cabinet Office Internal Fraud Hub and anyone included on the database will be refused employment unless they can show exceptional circumstances. Currently this is only for External candidates to the Civil Service.

Careers website

Please visit our careers site for more information https://gov.uk/ukhsa/careers

Salary Information

If you are successful at interview, and are moving from another government department, NHS, or Local Authority, the relevant starting salary principles for level transfers or promotions will apply. Otherwise, roles are offered at the pay scale minimum for the grade, but in exceptional circumstances there may be flexibility if you are able to demonstrate you are already in receipt of an existing, higher salary. Pay increases are through the relevant annual pay award for the role and terms.

Senior Executive Officer (SEO)

• £41,983- £48,128 (National)
• £44,148- £50,121 (Outer London)
• £46,310- £52,113 (Inner London)

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check.Successful candidates must meet the security requirements before they can be appointed. The level of security needed is counter-terrorist check (opens in a new window).

See our vetting charter (opens in a new window).People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• 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 European Union Settlement Scheme (EUSS) (opens in a new window)
• 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 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

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).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.

Diversity and Inclusion

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

Apply and further information

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : Charlene Gwekwerere
• Email : charlene.gwekwerere@ukhsa.gov.uk

Recruitment team

• Email : recruitment@ukhsa.gov.uk

Further information

The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission's Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email: Complaints@ukhsa.gov.uk If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website here.

http://www.healthjobsuk.com/vacancy/7840644