Analytical Characterisation Scientist

at  Morgan McKinley

Reporting to the Associate Director, Drug Product Engineering, as Analytical Characterisation Scientist, you will play an important role in the early establishment of the analytical lab function within the Process Development Department at Horizon, Waterford. You will bring a broad expertise in analytical development, qualification, validation, testing, technological expertise, and data interpretation to the team. You will implement commercial and development assays into the lab to support upstream and downstream drug substance process development /characterization studies. Additionally, you will support drug product heightened characterization via formulation development, process development and liquid and solid-state characterization studies. You will support commercial and development comparability programs and perform analytical product characterization as well as execution of forced degradation studies. You will assist in the development and optimization of new assays and trouble-shoot existing assays that are being used for release and stability testing of commercial and development products. You will assist in the design, development and execution of the process development studies in the drug product development laboratory.
Other responsibilities include supporting analytical deviations and CAPAs, authoring and reviewing analytical protocols and reports and authoring the method development, validation, and comparability sections of regulatory dossiers. The candidate will also be heavily involved in maintaining and enforcing our strong commitment to safety

Please refer the Job description for details