Process Scientist - Translation Unit
We offering an exciting opportunity for an experienced Process Development Scientist to join the fast-growing team within our Translation Group based in London. The position is a full-time opportunity, on a permanent contract.
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.
this role you will support the day-to-day development of processes to produce (genetically engineered) macrophages for therapeutic applications in inflammatory organ damage.
Specific responsibilities include:
- Supporting development of a GMP compliant manufacturing process for engineered macrophage cell therapy
- Supporting optimisation of established processes suitable for transfer to GMP manufacturing environment
- Accountable to analyse and present process data for use in project reports and presentations
- Establishing and writing standard operating procedures from developed processes
- Working closely with Translation, Cell Engineering and Macrophage Biology units in Edinburgh to perform technology transfer from research to GMP-compliant processes, and subsequently from process development to manufacturing facility
- Responsibility for training and supporting technology transfer to GMP manufacturing facility
- Supervisory oversight of GMP activities in both manufacturing and Quality Assurance for example, compliance to Quality Management Systems, involvement in documentation preparation: risk assessments, change controls, non-conformance & CAPAs
- Supporting the development of the Clinical Trial Dossier and regulatory-related documentation
- Accountable for good documentation practices for data recording
- Liaising with external vendors and suppliers
- Writing patents, publications, data analysis and protocols, reports and compilation of presentations as well as 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 will have the right to work in the UK, 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 Biology, Biochemistry, or a related discipline or equivalent experience
- Experience in Good Manufacturing Practice (GMP)/Good Clinical Laboratory Practice (GCLP) settings
- Experience in cell therapy process development
- An understanding of quality by design and developing an appropriate control strategy for products in development
- Experience with different primary cell culture and different culture systems
- Experience using cell processing equipment, including the CliniMACS Prodigy instrument and/or similar equipment
- Experience with single-use, automated and closed processing techniques
- Experience with bioprocess engineering and scale-up cultivation
- Experience with adherent and suspension bioreactor techniques
- Proven ability to work productively within a team
- Ability to take initiative and work independently
- Excellent time management and organisation
- Confidence to communicate effectively and clearly both verbally and in writing
- Ability to maintain accurate and up to date records
- A working knowledge of immunology and chronic inflammatory diseases, preferably chronic liver disease
- Experience in cell therapy process analytics
- Experience with multicolour cell flow cytometry and associated data analysis
- Experience with ELISA and MSD
- Experience with molecular techniques, such as PCR
- Understanding of Quality Management Systems
- Experience in a commercial laboratory environment
- Experience in biotechnology company
Incentives: An opportunity to participate in the Company's incentive share scheme
Benefits: Competitive package including pension, private health insurance, life assurance and income protection.