Scientist (CMC Analytical Development)
PsiOxus Therapeutics Ltd is an Oxford based development stage biotechnology company developing novel therapeutics for the treatment of cancer, with a focus on immunotherapeutic approaches. At PsiOxus we are advancing our internal early and clinical stage candidates and establishing strategic partnerships with immune-oncology leaders to bring our cancer gene therapy products to patients.
We have an exciting opportunity for an Analytical Scientist to join us and be part of an Analytical Development team to develop and run cell based, biochemical, physicochemical, immunochemical and other methods required to support drug development.
The Scientist will be working closely with team members and external contract testing and manufacturing organisations in order to perform QC release, stability and characterisation assays and analysis of clinical samples in accordance with Regulatory and Quality Guidelines.
Key responsibilities will include, but are not limited to:
- Taking a lead role in the invention and development of new techniques to support PsiOxus CMC related activities.
- Routinely performing and participating in the invention, qualification, development and validation of cell based, biochemical, physicochemical, immunochemical and other methods required to support manufacturing of PsiOxus products.
- Producing well written, compliant and traceable laboratory notebooks and reports.
- Providing training to other staff as necessary and appropriate.
- Writing and reviewing Analytical Development SOPs
- Assisting in the technical transfer of analytical methods to relevant Contract Testing Laboratories.
- Routinely performing product characterization and in process analysis to support product development activities.
- Communicating ideas and experimental designs with colleagues.
- Monitoring and communicating progress against objectives and highlight delays or potential risks to project timelines.
- Reporting on progress on a regular basis, both within the team and other program teams internally at PsiOxus and externally as necessary.
We are looking for a highly organised, self-motivated team player with excellent interpersonal and communication skills. You will be technically competent and capable of working independently in the laboratory, with the ability to work to tight deadlines and be able to readily adapt to changing priorities in a fast-paced environment. You will be highly innovative and have excellent attention to detail. In addition you will also have:
- A BSc or higher qualification in a life science discipline.
- Minimum of five years practical laboratory experience, most of which was in a Biotechnology/ Pharmaceutical setting.
- Experience in Biological Assay Development (understanding/applying ICH guidelines)
- Experience in Analytical Assay technical transfer, assay development or validation.
- Good practical knowledge of cell culture and a range of biological/immunochemical techniques.
- Ability to analyze and research complex issues and write factual reports.
The following skills and experience would be desirable:
Experience in Biochemical techniques such as HPLC, ELISA, SDS PAGE and Western Blot.
- Understanding of Design of Experiment and relevant software.
- Experience in cell culture and cell-based Bioassay.
- Knowledge of cGMP and assay troubleshooting and root cause analysis.
- Understanding of biological manufacturing process (upstream and downstream).
In return we offer an attractive remuneration package including salary, pension, private healthcare and other benefits. Please click here to apply and click on the Apply button to upload your CV and covering letter.
The closing date for applications is 26 July 2019, however applications will be evaluated in the order that they are received. You are therefore encouraged to apply as soon as possible.