Requirements: English
Company: IQVIA Italia
Region: italia, italy ,
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:
Masters 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 IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).