Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a Analytical Scientist who can join an exciting working environment in a dynamic and international atmosphere.
Purpose:
Design, monitor and data elaboration of analytical development studies relevant to inhalation (pMDI/DPI) and/or biological drug products.
Main responsibilities:
* Support 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 required: at least 5-year experience on inhalation products and/or biological drug products
Technical skills
* Good 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
Education: Master’s Degree or PhD in Chemistry or Chemical and Pharmaceutical Technologies
Languages:
English fluent
We offer:
* Competitive salary package
* Permanent contract
* Chemical contract
IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).