MAIN PURPOSE OF JOB
To develop methods for and perform process analytics to support process development and stability of ImmTACs and other TCR based molecules. To conduct and design experimental investigations, with appropriate guidance from colleagues and managers, enabling the advancement of the Company pipeline, process, or technology capabilities.
- Carry out process analytics for manufacturing campaigns.
- Analytical development and qualification of methods for process analytics in the ImmTAC product development.
- Methods include SDS PAGE, cIEF, CE-SDS, Host cell protein ELISA, Host cell DNA, Sterility testing, Endotoxin, ELISA, IEF, Western blotting.
- Perform testing to support stability of process intermediates and final drug product.
- Perform testing to support formulation studies.
- Stay up to date with industry and regulatory CMC requirements.
- Participation in laboratory maintenance.
- Priorities: working to agreed experimental priorities and deadlines; raising issues or concerns with managers or colleagues so that these can be addressed.
- Laboratory records: Ensuring that all records and data are up to date, on time and recorded to the correct standard, checking with a mentor or colleagues if unsure.
- Hands on expertise of SDS PAGE, ELISA assays and aseptic technique.
- A background in recombinant protein or antibody analytical development or QC, with 1 or more years’ experience gained in industry.
- BSc. in biochemistry, protein engineering, molecular biology or related discipline.
- Experience of capillary electrophoresis (CE SDS), gel based IEF, imaging capillary IEF (cIEF), Western blotting, HPLC.
- Some impurity testing experience (one or more of Host cell protein ELISA, Host cell DNA, Endotoxin, process residuals).
- Knowledge of GMP.
- Experience of lab organisation/maintenance.
- Proactive in ensuring high quality of their work and seeking additional responsibilities to help meeting the goals of the team.