Analytical Scientist - Translation
We are offering an exciting opportunity for an experienced Analytical Scientist to join the fast-growing team in our Translation Group based in London. The position is a full-time opportunity, on a permanent basis.
Resolution Therapeutics (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, RTx was launched with a £26.6m series A financing.
Today, RTx is a multidisciplinary team of experienced 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 analytical Group is focused on analytical development, qualification and/or
validation of cell-based and molecular assays for testing of cell-based material in preparation for
manufactured to GMP standards ahead of clinical trial application. The assays will be transferred, implemented and further developed from the R&D units or the Translation unit located in Edinburgh.
In this role you will support the strategic and day-to-day analytical development program for engineered macrophage cell therapy products for therapeutic applications in liver cirrhosis. You will work very closely with the Edinburgh based units to translate assays as developed by R&D to qualified assays suitable for routine QC testing according to GLP standards.
Specific responsibilities include:
- Accountable for the day-to-day in-process and final product testing required during the process development projects of the Translation Group
- Responsible for translation of research protocols to GLP compliant QC assays
- Responsible for development of assays and analytics to assess and confirm cell-based product characteristics and characterise genetically engineered macrophage candidates.
- Compilation of study protocols and reports associated with the development or characterisation of a cell-based or molecular assays
- Implement and tech transfer analytics to the GCLP lab for assessment of material intended for clinical use
- Accountable for the design of qualification and/or validation programs for QC assays
- Compilation of documentation for qualification or validation of assays
- Interfacing with CMOs for the qualification and / or validation of assays as part of the release strategy of cell therapy product(s)
- Establishment, development and execution of initial and ongoing stability studies
- Support the establishment of supply agreements with third-party testing laboratories
- Supporting the development of the Clinical Trial Dossier and regulatory-related documentation related to the analytical aspects of the cell therapy product(s), including risk assessments
- Writing patents, publications, data analysis and summarising data for progress reports and presentations; delivering presentations
You will report directly to the VP Analytics, Translation and will collaborate closely with others within and beyond the Translation Group.
The successful candidates be able to commute daily to Resolution Therapeutics in London and will have the following qualifications, skills and experience:
- A PhD degree / or equivalent experience in cell biology or immunology or a related discipline or equivalent experience
- Experience in Good Clinical Laboratory Practice (GCLP)
- 3 years' academic as well as industry experience in analytics, including with stem cell derived and gene modified cell therapy products
- Experienced flow cytometry user including panel design, assay development, execution and data analysis
- Experience in development and execution of cell functionality assays
- Experience in development and execution of molecular techniques, such as PCR
- Experience with ELISA and MSD
- Data analysis and associated techniques
- Proven track record in development, qualification and validation of cell and gene-based assays
- Proven track record in documentation generation, including compilation of standard operating procedures and test protocols
- Proven track record with different primary cell types and associated culture techniques
- Proven ability to work productively within a team, with clear leadership skills
- Ability to maintain accurate and up to date records
- A working knowledge of immunology and chronic inflammatory diseases, preferably chronic liver disease
- Experience Good Manufacturing Practice (GMP) settings
- Experience with analytical technology transfer
- Experience in development and execution of cytotoxicity assays
- Experience in genetic stability testing
- Experience developing advanced therapeutic medicinal products
- Experience using high throughput imaging e.g. Operetta
- Experience in a commercial laboratory environment
- Experience in a small biotechnology company
- Understanding Quality Management Systems
Incentives: An opportunity to participate in the Company's incentive share scheme
Benefits: Competitive package including pension, private health insurance, life assurance and