Process Development Scientist

We are looking for a passionate and curious Process Development Scientist to join our Drug Substance Development team.

The ideal candidate will participate in the development of the manufacturing process for the synthesis of New Chemical Entities (NCEs).

The job activity will mainly focus on the development of crystallization processes, solid-state characterization of the produced materials, and process safety assessments.

Main Responsibilities

The candidate will be part of a team aimed at ensuring the solid-state consistency of Chiesi NCEs and the safety of the related processes, collaborating with the Process Development team, analytical development, and QC groups. The main responsibilities include:

1. Actively participating in process development for the synthesis of New Chemical Entities, focusing on the isolation of the active ingredient.
2. Planning and executing Process Risk assessments and experimental trials.
3. Designing, performing, and monitoring investigations related to the solid-state properties of new drug substances and process safety studies.
4. Analyzing data and elaborating experiments using appropriate statistical and data analysis tools.
5. Exploring modeling tools to streamline robust process scale-up.
6. Producing process development reports and technical packages for technology transfer related to their contributions.
7. Managing laboratory equipment and maintaining optimal operating conditions.
8. Supporting small-scale productions of intermediates and active ingredients for technological and toxicological studies in non-GMP environments.
9. Supporting the transfer of processes to GMP manufacturing units or CDMOs.
10. Providing consultancy for lifecycle management and troubleshooting of industrialized products.

Experience Required

Academic or industrial experience in developing crystallization processes.

Education

A degree or PhD in Chemistry or related fields, with a deep understanding of thermodynamics (calorimetry), organic reactions, and industrial processes.

Languages and Technical Skills

• Sound knowledge of pharmaceutical solid polymorphism principles.
• Knowledge of analytical techniques such as XRPD, DSC, PSD, DVS, BET, microscopy.
• Basic understanding of statistical tools like Design of Experiments and Principal Component Analysis.
• Knowledge of programming languages such as Python and fluid dynamics modeling is a plus.

Soft Skills

• Strong planning and organizational skills.

What We Offer

Join a dynamic, fast-growing, challenging, and friendly environment. At Chiesi, we believe our people are our most valuable asset, investing in continuous training, learning, and development. We promote a positive working environment and collective well-being.

We value work-life balance, offering flexible work arrangements, remote work options, relocation support, tax assistance for foreign colleagues, and other people-care services.