Principal Scientist, Drug Substance Process Engineering

Job Title: Principal Scientist, Drug Substance Process Engineering

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. J

We are looking for a highly motivated individual with a mindset to implement changes who is recognized as technical expert in the field of data and modelling with expertise in application on pharmaceutical processes. The Senior Scientist will work in a cutting-edge scientific department to demonstrate the benefits of system modeling and data science developing the next generation of Sanofi medicines that will improve the quality of life for patients across the world. This role is part of the newly formed Process Operation Data and Modeling department of the CMC Synthetics organization located in Waltham, MA, and will ultimately move to Cambridge, MA.

This role will directly manage a small team of up to 4 scientists and lead matrix teams to support the application of modelling and data processing across the entire New Chemical Entity (NCE) Synthetics portfolio. The team is responsible for the development of the small molecule NCE portfolio and the process improvement of the legacy portfolio. Process development may be directed to either batch or continuous processes.  We strongly believe that innovation in process development and manufacture, data science and process modelling will be the key driver to unlock the future of Pharma.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Directly engage and communicate with key business and technical stakeholders (Director level and above)

• Develop effective collaborations with others within project teams (chemists, analysts, and chemical engineers from across Sanofi R&D) and partner lines (such as Development Operations, Manufacture, Regulatory).

• Identify opportunities to utilize innovative modelling methodology to streamline the process development activities and facilitate optimal decision-making.

• Lead the development and implementation of new and existing workflows and methodologies.

• Bring and share knowledge and experience of Active Pharmaceutical Ingredient (API) and Drug Product (DP) development and manufacture processes.

• Support development activities such as process design, optimization and process control in both API and DP domains using modelling technology.

• Leverage engineering modeling and data science to efficiently support development, design space definition and optimization manufacturing processes. 

• Partner with experts in process analytical technology, automation and control to enable the delivery of integrated unit operations for API development and manufacture.

• Support technology transfer of API processes to internal Sanofi API manufacturing facilities and external suppliers

• Provide expertise to the Synthetics organization for the development and application of new and existing continuous process technologies to enable development and transfer of safe and scalable processes to API manufacturing facilities.

• Collaborate and author external publications and present research at external conferences.

About You

Basic Qualifications:

• PhD with minimum of 4 years of relevant industry experience or a Master’s degree with 8 years of relevant industry experience

• Experience managing direct reports and/or project teams

• Strong scientific track record in system models and process simulations

• Strong scientific track record in the following fields: Pharma 4.0, continuous processing, high throughput experimentation.

• Domain knowledge in small molecule with direct experience in either API or DP development or manufacturing

• Experience applying gPROMS, Matlab, Aspen, Python, DynoChem or similar in API or DP development or in Biopharmaceutics modeling.

• Advanced scientific network within academia and industry.

• An ability to work as part of a team, engaging other scientists with complementary skill sets in the field of Biopharmaceutics

• A change agent mentality, proposing novel approach to challenging scientif