Our client in the Lugano area is looking for an Analytical Laboratory TechnicianContract: 6 months with possibility of extensionsTasks - ResponsibilitiesPerform release analysis of raw materials, process intermediates, drug substances and drug products in accordance with GMPPerform stability and in process control analyses in accordance with GMPPerform analyses for the characterisation of reference materials or reference standards using: HPLC, KF, GC, electrophoresis, ELISA, enzymatic assays, etc.
Develop, qualify and/or validate new analytical methods;Perform analytical transfer to the quality control departmentPrepare reports in support of project activitiesOperate in compliance with cGMP and safety regulationsProfessional knowledge/skillsAutonomy in performing analytical methods and knowledge of HPLC. Knowledge of additional analytical techniques such as ELISA, SEC, LC-MS, CE, IEC, KF, GC, will be considered a plusKnowledge and experience in the development and validation of analytical methodsKnowledge of analytical methods for the characterisation of biotechnological products (recombinant proteins, ADCs, mAbs); practical knowledge of Analytical QbD/statistical techniques (ANOVA, linear regression, statistical tests, DoE).
Good knowledge and experience of GMP regulationsExperience in handling HPAPIGood knowledge of the English land Italian languages;
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