Analytical Scientist – Translation Full Time on the ground

Analytical Scientist – Translation We are looking for an experienced Analytical Scientist to join the fast-growing team within our Translation Group based in Edinburgh. This position is a full-time opportunity on a permanent basis. RTx is a biotechnology company developing macrophage cell therapies to treat inflammatory organ disease. The company’s technology platform is based on over a decade’s work by Prof. Stuart Forbes and Prof. John Campbell, and provides RTx with a leading position in macrophage biology and regenerative medicine. In 2020, following a productive collaboration between Edinburgh’s Centre for Regenerative Medicine, the Scottish National Blood Transfusion Service, and Syncona, Resolution Therapeutics was launched with a £26.6m series A financing. Today, RTx is a multidisciplinary team of experience scientists, engineers and entrepreneurs based in Edinburgh and London, working at the forefront of cell therapy and liver disease, supported by Syncona, Europe’s leading life science investor. The Translation Group is focused on development, characterisation, qualification and/or validation of cell-based and molecular assays for testing of Clinical Trial Material manufactured under GMP conditions. The assays will be transferred, implemented and further developed from (1) the R&D macrophage biology department or (2) adapted as used in a previous Clinical Trial using a non-engineered macrophage product. In this role you will support the strategic and day-to-day development and implementation of assays and analytics characterising genetically engineered macrophages for therapeutic applications in liver cirrhosis. Key responsibilities: Supporting the day-to-day in-process and final product analytical testing required during the process development projects of the Translation Group Development of assays and analytics to assess and confirm cell-based product characteristics Development and refinement of assays and analytics to characterise genetically engineered macrophage product candidates Establishment, development and execution of stability studies Interfacing with the Cell Engineering and Macrophage Biology Units to translate research protocols and develop standard operating procedures for the GLP environment Interfacing with SNBTS for the qualification and/or validation of assays as part of the release strategy of the macrophage gene-modified macrophage cell therapy Supporting development of an end-to-end GMP/GLP production process and testing profile Implement analytics in the GCLP lab for assessment of material intended for clinical use Compilation of study protocols and reports associated with the development or characterisation of a cell-based or molecular assay Compilation of documentation for qualification or validation of assays Support the establishment of supply agreements with third-party test labs Supporting the development of the Clinical Trial Dossier and regulatory-related documentation related to the analytical aspects of the gene-engineered macrophage cell therapy, including risk assessments Writing patents, publications, data analysis and summarising data for progress reports and presentations; delivering presentations You will report directly to the Group Leader, Translation and will collaborate closely with others within and beyond the Translation group. The successful candidate must have the following qualifications, skills, and experience: A MSc in cell biology or immunology 3 years’ academic as well as industry experience in analytics, including with gene- modified cell therapy products Experience in Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) settings Proven track record in development, qualification and validation of cell and gene-based assays Proven track record with different primary cell types and associated culture techniques Proven track record in documentation generation, including compilation of standard operating procedures and test protocols Data analysis and associated techniques Experience with flow cytometry and magnetic bead separation (MACS or similar) Experience with analytical technology transfer Proven ability to work productively within a team, with clear leadership skills Ability to maintain accurate and up to date records Preferable skills/experience include: A working knowledge of immunology and chronic inflammatory diseases, preferably chronic liver disease Experience developing cell therapies Experience using the CliniMACS Prodigy instrument and associated equipment Experience in a commercial laboratory environment Experience in a small biotechnology company Selection process: Following your application, an initial call will be scheduled by the Recruitment Partner before being shortlisted. If successful, you will be invited to start the interview process which consists of 3 stages: Initial meeting with the Hiring Manager and another member of the RTx team Presentation & panel interview Conversation with the CEO Please be aware that due to the volume of applications, feedback will not be provided at the application stage. Benefits: Our competitive package includes pension, private health insurance and life assurance, as well as an opportunity to participate in the Company’s incentive shares scheme. Please direct any questions and CVs in the first instance to our Recruitment Partner, Poppy Boronat ( poppy.boronatlifesciencepeople.co.uk ).