We are currently looking for a British Pharmacopoeia (BP) Specialist to join our Standards and Compliance Function within the Innovation and Compliance group.
This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas. We are open to requests for flexible working. Please discuss this with the recruiting manager before accepting an appointment.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

WHO ARE WE LOOKING FOR?

Our successful candidate will:

• a degree in a scientific discipline relevant to pharmaceutical quality as detailed in the person specification.
• experience of applying expert technical knowledge to develop quality standards for healthcare products.
• strong knowledge of analytical techniques and processes used in the determination of pharmaceutical quality

• experience of working in a regulated pharmaceutical environment or equivalent.broader awareness of trends in the life sciences, biopharmaceutical manufacturing and regulatory environment and ability to assess potential impact on the work of the pharmacopoeia.

• 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.
• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
• Test, further information will be supplied when you reach this stage
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of candidates having experience of applying expert technical knowledge to develop quality standards for healthcare products .
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 competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

WHAT’S THE ROLE?

Play a unique role at the MHRA by leading the development of legally binding standards and guidance for the British Pharmacopoeia (BP).
Use your scientific expertise to manage the standard setting process from initial inception through development and publication as well as ongoing maintenance.
Work with, manage and influence BP Expert Advisory Groups, engage with the pharmaceutical industry in the preparation of draft standards and support the future development of our Pharmacopoeia and regulatory science strategies.

Key responsibilities:

• To contribute and support the work of the BP Commission to develop and implement appropriate standards and policy, including leading the work to support at least two BP Expert Advisory Groups/Panels/Working Parties or equivalent activity.
• To lead or assist in managing specific scientific or delivery areas/projects to ensure or improve the standards and services that we provide to our users. For example, activities such as coordinating the work to produce the text for the BP and BP Vet, or development of scientific strategy/policy.

• To ensure that the interests of the BP and Laboratory Services Group are promoted strongly and positively through appropriate communication and joint working with internal and external organisations.To support the work of the European Pharmacopoeia (Ph Eur) Commission. To participate as a UK expert in Ph Eur working groups in the development of Ph Eur standards, as required.

This role is open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants). Appointments to roles within MHRA will be made in accordance with the Civil Service Nationality Rules (CSNR). These can be found at https://www.gov.uk/government/publications/nationality-rules . This job is broadly open to the following groups:

• UK nationals
• Nationals of Commonwealth countries who have the right to work in the UK
• Nationals of the Republic of Ireland
• Nationals from the EU, EEA or Switzerland with settled or pre-settled status or who apply for either status by the deadline of the European Union Settlement Scheme (EUSS)
• Relevant EU, EEA, Swiss or Turkish nationals working in the Civil Service
• Relevant EU, EEA, Swiss or Turkish nationals who have built up the right to work in the Civil Service
• Certain family members of the relevant EU, EEA, Swiss or Turkish nationals
• This vacancy is also open to individuals normally exempt under the CSN