Who we are looking for
Purpose
Testing of materials suitable for preclinical and clinical development, and registration of new drug substances, including starting materials and intermediates, also in accordance with GMP/cGMP
Main Responsibilities
• Method development to characterize new starting materials, intermediates and active ingredients
• Execution of the activities described in the method validation/transfer protocols
• Execution of the activities described in the stability protocols
• Execution of the activities described in the forced/stressed degradation protocols
• Analytical testing of materials for clinical use and non-clinical use
• Analytical testing to support process development of new active ingredients
• In Process Controls during new active ingredients manufacturing campaigns
• Analytical testing to verify plant cleaning
• Equipment management
• Support to the management of analytical non conformities (deviations, OOS, OOT, OOE)
• Promote the technological innovation, scientific understanding and best practices
• Promote operational excellence (processes/best practices) and continuous quality improvement
• Preparation and revision of technical documentation
Experience Required
2-5 years as Analytical Technician in Quality Controls laboratories of active ingredients manufacturing companies, pharmaceutical companies, chemical companies
Education
High school diploma in Chemistry
Languages
English – basic knowledge
Technical Skills
* Very good knowledge of UHPLC with UV-Vis/DAD/PDA and Mass detectors
* Very good knowledge of GC with Flame Ionization and Mass detectors
* Good knowledge of IR, Raman, NIR, UV-Vis spectrophotometer, DSC, TGA, potentiometric titrators in aqueous and non-aqueous medium, KF volumetric and coulometric titrators, ICP-MS, laser diffraction equipment for particle size distribution measurement
* Good knowledge of the Good Manufacturing Practice rules applied to the analytical laboratories
* Good documentation editing skills
* Good knowledge of the univariate statistic
* Good knowledge of the standard informatic tools
* Knowledge of pKa and logP/D determination
* Knowledge of problem-solving techniques
* Knowledge of the multivariate (PCA, DoE) statistic
Soft Skills
* Decision making
* Planning and organizational skills
* Team working
* Continuous learning
* Goal orientation
What we offer
You 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.