Senior Scientist - Pharmaceutical Engineering

Sanofi

Montpellier, France

As Senior Scientist within our Pharmaceutical Engineering team in the CMC Synthetics Platform, you'll drive mechanistic understanding, modeling implementation and technological solutions identification for the development of drug product processes for new synthetic molecular entities. Ready to get started?

You'll be at the forefront of Sanofi's transformation from traditional experiment-heavy development to a digital approach using in-silico experimentation, high throughput data generation, automation and robotics to accelerate knowledge generation and increase efficiency. Working closely with Drug Product Development and Crystallization and Particle Engineering groups, you'll contribute to designing robust and efficient processes that meet quality targets.

Main responsibilities:

• Responsible for working with internal and external resources (e.g. collaborations) to development material sparing tools to predict manufacturability in early development
• Propose and generate, within the framework of development projects, specific activities requiring physicochemical and process expertise to support the development of assigned clinical and commercial products
• Tasked with creating digital development workflows and software tools (e.g. APPs) for unit operations (e.g. powder feeding, blending, compression) and guiding implementation with partners during Process Selection, Process Design, Process Optimization and Process Scale-up
• Leading a transition to Process Characterization using Digital Twins vs traditional experimentally heavy protocols. Engaging Statistical Science to define confidence for Digital Twins for internal use and to include in regulatory filings
• Contributing and streamlining Tech Transfer in close collaboration with Manufacturing to ensure that robust processes are used for PPQ and commercial launch
• Championing the use of digital tools, new technologies and automation and robotics to enable continuous improvement of risk assessment throughout development
• Communicate achievements and significant contributions within projects
• Responsible for staying up to date with current regulatory approaches and authoring Drug Product sections regulatory filings
• Complying with all internal and applicable government Quality and HSE (Health, Safety and Environmental) requirements

About you:

• Experience: Has demonstrated ability to identify and develop impactful modelling applications and technological engineering solutions for Drug Product development. This includes the ability to design experimental plans and propose representative use-tests to collect data required up to the translation of conceptual mathematical models to computer models. Has experience operating in a fast-paced environment leading engineering work packages development individually or through matrix teams
• Soft and technical skills: A strong understanding of process engineering and solid-state physical characterizations. Demonstrated skills with computer programming using software such as gProms, Matlab and Python. A basic understanding of statistical concepts and data engineering to effectively work with respectively our biostatisticians and IT partners on data exploitation and integration. A good technical knowledge of the state of the art of the available manufacturing and characterization equipment available on the market
• Education: Masters in Chemical Engineering or related field minimum + 3 years experience
• Languages: English and French is a bonus