Principal Scientist, LNP Drug Product Characterization (Biophysics and Analytics) - Vaccines

Job title: Principal Scientist, LNP Drug Product Characterization (Biophysics and Analytical) - Vaccines

Location: Waltham, MA

In the race for the future of health– The Sanofi mRNA Center of Excellence (CoE)

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.

That’s why we’re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!

As the Principal Scientist within the Drug Product Platform and Early Clinical Development Team, you will provide hands-on leadership to a small team focusing on LNP analytics to characterize LNP Drug Products. The Principal Scientist will be responsible for method transfer of core LNP characterization methods from Analytical Sciences, establishing and training team, and building strong relationships with Analytical Science, and Lab Team Leaders/Unit Heads within the DP Development team to ensure robust analytical results are generated to help drive LNP formulation and process development initiatives. The Principal Scientist will need a deep scientific understanding of biophysical characterization methods, and the use of chromatographic and spectroscopic techniques to support the development of new LNP formulations for the CMC team in the mRNA Center of Excellence with the ultimate goal of to contribute to Sanofi’s goals of bringing innovative new mRNA vaccines to the market. This role will work across multiple teams and functions (CMC Drug Product Development, Analytical Science, Research Formulation and Delivery, and CMC Regulatory) and potentially different stages of drug product development to seek innovation in biophysics-related characterization and support project development, including troubleshooting and automation.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.​

Main Responsibilities:

• Build/Lead a team (1-2 contractors) to meet the biophysical characterization and analytical needs of the DP Platform and Early Clinical Development Team.

• Act as the team’s liaison to Analytical Science and build strong working relationships with key stakeholders to ensure methods are fully aligned between the two teams and swiftly implement necessary changes/improvements.

• Develop a robust sample testing strategy, including sample tracking, data reporting, and iLab integration.

• Represent Drug Product Platform and Early Clinical Development team and collaborate cross-functionally in the design, development, and execution of biophysical characterization studies to enable the development of a new LNP platform.

• Supervise and mentor junior scientists for LNP drug product characterizations and manage the operation of analytical requests within the Platform and Early Clinical Development team.

• Provide scientific insights through the lens of biophysical science (particle size measurement, zeta potential determination, particle morphology, internal structure determination, lipid fluidity, and nucleic acid-lipid interaction), and chromatography analysis to support the development of new-generation LNP vaccines, including considering the vaccines' thermostability, potency, and manufacturing process.

• Support the technology transfer of drug product formulation and process to toxicology batch and pilot scale as needed.

• Represent function in cross-functional and strategic teams engaged in novel mRNA vaccine development.

• Analyze, interpret, and summarize results in techn