Who we are looking forPurposeDesign, monitor and data elaboration of analytical development studies relevant to inhalation (pMDIs/DPI) and/or biological drug products Main ResponsibilitiesSupport to CTS release.Study Monitor of analytical method development studies.Study Monitor of analytical method validation/transfer studies.Study Monitor of stability studies.Study monitor of active ingredients characterization studies.Support to formulation and process development studies of drug products.Support to scale up for drug products and active ingredients process.Support to device characterization studies.Support to the critical quality attribute identification of APIs and drug products.CRO management Experience RequiredAt least 5-year experience on inhalation products and/or biological drug productsEducationMaster degree or PhD in Chemistry or Chemical and Pharmaceutical TechnologiesLanguagesGood working knowledge of English.
Italian would be advantageous Technical SkillsGood knowledge of the spectrophotometric, diffractometric, calorimetric, potentiometric and chromatographic techniques.Good knowledge of the univariate and multivariate (PCA, DoE) statistic.Good knowledge of the standard informatic tools.Good knowledge of the analytical characterization of inhalation devices.Good knowledge of the analytical characterization of inhalation active ingredients and drug products.Good knowledge of the analytical tools for the characterization of the inhalation performances (DUSA/USCA/NGI/ACI).Good knowledge of GMP/cGMP and guidelines (ICH, EMEA, PQRI, Health Canada) related to the pharmaceutical development of inhalation products.Good knowledge in biological product development from preclinical/early phase to the late phase/Market is considered as a plus Soft SkillsAnalytical skillsPlanning and organizational skillsTeam workingQuality orientationWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
