Be part of a company who are leading the world in their research in therapies for personalised oncology treatments.
Our client is Principal/Head QC Scientist who will lead a small team supporting GMP operations. You will be responsible for performing all QC related assays for T cell therapies that are entering the clinic later this year in a phase I/II trial. You will develop the team strategy with other company leaders on QC documentation implementation and assay validation in line with GxP and MHRA ATMP standards. In the addition you will lead on supporting both the tech transfer and process development teams on all QC related activity to enable introduction of new manufacturing processes and analytical techniques. This role will be based in their facilities in Greater London.
Suitable candidates will need to possess skills/experience in the following areas:
- Several years’ experience of working in a QC and GMP environment
- Technical expertise with immunoassays including multicolour flow cytometry and ELISpot
- Qualification and validation of assays and equipment
- SOP, Validation and Qualification documentation preparation and implementation
- Manage QC activities for tech transfer and manufacture of ATMP
- Review and analysis analytical and lab data (flow cytometry)
- Knowledge of QC testing e.g endotoxin, sterility, environmental monitoring and mycoplasma
- Knowledge of biopharmaceutical and cell-based techniques including immunohistochemistry, PCR, DNA/RNA isolation, cytotoxicity and cell Proliferation Assays
This company is well resourced and financed with significant growth plans.
Please forward your CV to Alex Butcher or phone 01403 216216 where we would be happy to tell you more about this exciting Senior Scientist opportunity.