Who we are looking for
Purpose
We are looking for a passionate and curious Process Development Scientist to join our Drug Substance Development team.
The ideal candidate will participate to the development of the manufacturing process for the synthesis of New Chemical Entities (NCEs).
The job activity will be mainly focused on the development of crystallization processes, solid-state characterization of the produced materials and on process safety assessments.
Main Responsibilities
The candidate will be part of a team aimed to ensure the solid-state consistency of Chiesi NCEs and the safety of the relative processes, together with the Process Development team, the analytical development and QC groups. The main responsibilities will encompass:
• Actively participating in the process development for the synthesis of New Chemical Entities, with a focus on the isolation of the active ingredient.
• Producing Process Risk assessment planning and executing the relevant experimental trials.
• Designing, performing, and monitoring drug substance investigations related to the solid-state properties of new drug substances and process safety studies.
• Performing data analysis and elaboration of data-rich experiments with proper statistical and data analysis tools.
• Exploring the use of modelling tools to streamline robust process scale-up.
• Producing process development reports and technology transfer technical packages or parts thereof, related to his/her contribution to the project.
• Managing and taking care of laboratory equipment and the general operating conditions of the laboratory.
• Supporting small productions of intermediates and active ingredients for technological use and for toxicological studies in non-GMP regulated environment.
• Supporting the transfer of processes to the GMP manufacturing unit or to a CDMO.
• Providing consultancy for Life cycle management and troubleshooting for already industrialized products.
Experience Required
Academic or industrial experience in the development of crystallization processes.
Education
A degree/PhD in Chemistry or related fields, with deep understanding of thermodynamics (calorimetry), organic reactions and industrial processes.
Languages
English fluent
Technical Skills
• Sound knowledge of general principles of pharmaceutical solid polymorphism
• Knowledge of analytical techniques for the characterization of pharmaceutical solids (XRPD, DSC, PSD, DVS, BET, microscopy…)
• Basic understanding of statistical tools for multivariate data analysis, like Design of Experiments and Principal Component Analysis
• Knowledge of programming languages such as Python and fluid dynamics modelling will be considered a plus.
Soft Skills
* Planning and organizational skills
* Team working
* Attention to details
* Communication skills
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.