Immunocore is an innovative and dynamic biotechnology company developing a unique platform of T Cell antigen receptor-based therapeutics, called ImmTACs, as a novel class of treatments for cancer.
Immunocore has a well- established pipeline of wholly owned programmes, of world leading science and strong IP position, which has led to discovery collaborations with Genentech, GlaxoSmithKline, Medimmune as well as a co-discovery & co-development partnership with Lilly, and recent investment from the Bill & Melinda Gates Foundation.
This role provides scientific and technical leadership to an expanding group of scientists supporting analytical development work through the product life cycle from pre-clinical to license. Work will be focused on (U)HPLC (ion exchange, size exclusion, reversed phase) and capillary electrophoresis (CE/icIEF) methods.
- Oversight of late phase validation studies for drug substance and drug product release testing at contract manufacturing organisations, including reviewing protocols and reports against ICH guidelines to ensure methods are fit for purpose.
- Compiling reports and preparing analytical sections for regulatory submissions (IND/IMPD/BLA/MAA).
- Study director for assay qualification studies of lot release methods and characterisation studies as required, supporting transfer to QC laboratories.
- Participating in project teams as an analytical lead.
Other responsibilities may include:
- Identifying new analytical techniques to continuously improve the product.
- In-depth characterisation and identification of product impurities and establishment of a control strategy.
You will need experience of late phase validation programs for biologics and are familiar with the principles of GMP. You will be established as an expert amongst peers in (U)HPLC or capillary electrophoresis (CE or icIEF) of biopharmaceuticals/recombinant proteins. Experience of immunoassay and/or mass spectrometry methods will be an advantage.
If you have contributed to CMC sections of IMPDs and INDs and have experience of process validation that will be a significant advantage.
You will need a BSc or MSc or equivalent in protein engineering, microbiology, biochemistry, molecular biology or related discipline. A PhD in a related discipline is desirable but not essential for this role.