JOB SUMMARY

We are currently looking for a Head of Formulation Science to join our Science, Research & Innovation group.
This is a full-time opportunity, on a permanent basis. The role will be based lab based in South Mimms, Hertfordshire.

JOB DESCRIPTION

The Head of Formulation Science will provide scientific leadership and expertise in the formulation and stabilisation of biological reference materials. This role is critical in supporting the development of international standards that serve as the foundation for the safety and efficacy of biologics. The successful candidate will lead a team of experts focused on lyophilisation and physicochemical characterisation, ensuring the development of robust and stable freeze-dried reference materials for global standardisation efforts.
As a key figure within the Analytical and Biological Sciences Division, you will collaborate closely with internal and external partners, including international regulatory bodies, research institutions, and industry leaders. Your expertise will contribute to the formulation and characterisation of biological medicines, advancing the science that underpins regulatory decision-making.

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)
• 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

KEY RESPONSIBILITIES AND RESULTS AREAS

The role provides expertise & research capability in the area of biologics stabilisation and formulation.
The role holder will act as the Principal Scientist and the key responsibilities for the role are:
Leadership and management:
• Lead and line manage the Formulation Science Section within the ABS Division.
• Lead research and development activities related to formulation and freeze-drying of biological
materials to achieve SR&I’s and the Agency’s goals.
• Provide expert advice and subsequent implementation of trial formulation and freeze-drying
conditions for all biological standards prepared at MHRA’s Science Campus requiring
lyophilization.
Service delivery:
• Direct / maintain an Internationally recognised research program related to freeze-drying and
formulation of biologicals.
• Promote the MHRA’s Science Campus research work and capabilities through
national/international forums as a resource/expertise in lyophilization with an expectation of
publishing in peer reviewed papers and presenting at relevant national and international
conferences.
• Identify opportunities for commercialization as well as secure and manage income from grants
and contract activities.
• Interact closely with the of Heads of Vaccine and Therapeutic Reference Materials and other
CBRM Managers to participate, advise, troubleshoot and influence the direction of the operation
and exploitation of the CBRM resource to SR&I and the Agency’s benefit.
• Through membership of internal boards provide specific expertise to the benefit of the whole
organisation.
Quality and Assurance:
• Manage section in accordance with ISO standards (ISO 9001).
• Manage generation and maintenance of associated documentation (e.g. Standard Operating
Procedures (SOPs), Design Dossiers) and those related to Health and Safety (e.g. risk
assessments) in compliance with the Agency’s policies.