The Biopharaceutical CMC solutions team is focused on providing analytical support in the drug development pathway for the characterisation and stability assessment of large protein molecules, including: vaccines, antibodies, cytokines and growth factors. The accurate characterisation of a drug is necessary to release manufactured batches of the drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. This is achieved using a variety of analytical techniques such as: Mass Spectrometry, SDS-PAGE, Western blotting, Isoelectric focusing, Capillary electrophoresis, HPLC, UV spectroscopy, ELISA, amino-acid analysis and peptide mapping.
Our protein mass spectrometry service offering focuses primarily on intact mass analysis, peptide mapping, characterisation of post-translational (or other) modifications (e.g deamidation, oxidation, di-sulphide bridging), analysis of glycosylation profiles and quantification. We are looking to expand on our capabilities in these areas.
Working within a dedicated BioCMC assay development team, the successful candidate will be involved in the development of protein mass spectrometry workflows and will primarily be responsible for method establishment, validation and application to characterisation studies in a GMP environment.
The Subject Matter Expert will liase closely with the QC Scientists who have overall responsibility for the scientific, technical and regulatory conduct of these studies and will facilitate data interpretation and documentation and reporting of results.
The role will primarily be lab based and responsibilities include:
A degree in a relevant scientific subject is required.
The successful candidate is expected to have experience working with proteins and with QTOF, ion-trap and tandem quadrupole instrumentation, ideally in a CRO environment with knowledge of UK/ OECD GXP regulations.