Head of Formulation Science

Job Title: Head of Formulation Science

Organisation: Medicines and Healthcare products Regulatory Agency

Location: South Mimms

Type: Permanent

Salary: £73,324 - £80,000 per annum (+c.29% employer pension contribution)

Allen Lane is supporting the Medicines and Healthcare products Regulatory Agency in their search for a new Head of Formulation Science on a permanent basis.

The MHRA enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. Recognised globally as an authority in its field, the agency is made up of c.1600 staff. The MHRA’s laboratories are located in South Mimms (near Potters Bar), the location for this role.

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.

This is an exciting opportunity for an experienced scientist with a strong background in protein chemistry, analytical chemistry, and lyophilisation to play a key role in shaping the future of biological medicines standardisation. Your work will directly contribute to ensuring the safety and efficacy of biologics used worldwide, making a tangible impact on public health.

Applicants should demonstrate their skills and experience against the following essential criteria in their CV and supporting statement:

• PhD in relevant scientific subject area, protein chemistry, analytical chemistry, lyophilisation, formulation and the characterisation of the products along with a proven track record of having held a managerial/supervisory role in a laboratory setting.
• Project management knowledge. Prince 2 qualified to practitioner level or equivalent experience is desirable.
• Thorough understanding of the development process and role of International Standards and reference materials and wider metrology issues with the quantitation of biological medicines.
• Strong familiarity/understanding across a very broad range of scientific disciplines e.g. across haematology, biochemistry, immunology and microbiology/virology, especially in areas related to the development and characterization of biological medicines & reference materials to control them.
• Wide knowledge/expertise in areas of chemical and microbiological safety.
• Proven experience of setting up resource and maintaining a laboratory footprint to deliver on the core role. E.g. complex valuable equipment which requires precise adjustment and calibration (freeze drying microscopy, differential scanning calorimetry, thermogravimetric analysis, dynamic mechanical analysis, HPLC, robotic filling and coulometric moisture analysis, non-invasive moisture and oxygen sensing technologies, pilot scale freeze dryers).
• Proven track record of maintaining and developing research programs and active research collaborations with other researchers nationally and worldwide to seek and implement research grant funding for such research. Evidence of relevant publications in peer reviewed journals is a must for the post holder. As well as experience and confidence in presenting to large and small audiences of scientists from different specializations and conveying complex data in a manner which is relevant and understandable.
• Desirable experience in biopharmaceutical manufacturing (GMP) and the scientific basis/regulatory requirements governing such activities. Relevant industry experience and familiarity in formulation freeze drying and ideally experience of tech transfer or at process scale, operating to ISO 9001, GMP and other regulatory guidelines.

You will also exhibit the following Behaviours, which you will be assessed against if Shortlisted:

• Delivering at Pace
• Working Together
• Developing Self and Others

Click here to view a comprehensive candidate pack, which details further information on the role specification.

The post holder will have access to the Civil Service pension scheme, which has an employer contribution of 28.97%, as well as a generous annual leave entitlement.

To apply, applicants must provide a tailored CV, supporting statement (up to 1,250 words) explaining your suitability for the role and a completed diversity monitoring form.

The application deadline is Monday 23rd June by 9:00am. Applications must be sent to [email protected]. Interview are intended to take place in WC 7th July.