Scientist​/Engineer

Job title:

Scientist / Engineer

Location:

Waltham, MA

The USA-mRNALNP Drug Product Team supports the Formulation and Process Development group in Waltham, MA, and reports to the DPGroup Lab Team Lead. We are seeking an individual with process development and/or formulation and good laboratory skills and scientific understanding of formulation development experience to contribute to bringing innovative new vaccines to the market. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research.

In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people’s lives.

• Lead the formulation optimization and/or process understanding of mRNA-containing lipid nanoparticle (LNP) formulation and production processes encompassing a wide range of different mRNAs and novel lipids.
• Work closely with the Research team in transferring and accelerating new LNP composition formulation into CMC development.
• Design and conduct small-scale multi-component LNP formulating experiments to understand the develop ability of new LNP formulations.
• Lead the compilation of Develop ability package for new LNP formulations.
• Develop initial formulation process for new LNP formulations.
• Design and arrange studies to assess the stability of new LNP formulations.
• Performing in-process drug product characterization.
• Perform complex and routine analytical methods to characterize new formulations and to troubleshoot as needed.
• Coordinate/Suggest/Introduce advanced LNP characterization analysis with the Analytical Sciences department.
• Support the Drug Product team to troubleshoot technical, formulation, and processing issues.
• Document development study set up, results, and conclusions within an electronic lab notebook.
• Tabulating and analyzing in-process and post-process characterization data.
• Summarize and present study progress, generated data, and analysis to other scientific team members and larger group meetings.
• Supporting the growth and expansion goals by setting up and installing new characterization and process equipment into new laboratories.

• Basic Qualifications Bachelor's in Engineering, Pharmaceutical Sciences, or Chemistry related science discipline, with 5 or more years of professional experience in formulation and/or process development
• Master's in engineering, Pharmaceutical Sciences, or Chemistry related science discipline, with 3 or more years of professional experience in formulation and/or process development. Internships and co-ops experience will be considered
• Ph.D. in Engineering, Pharmaceutical Sciences, or Chemistry related science discipline, with a minimum of 6 months of experience in formulation and/or process development.
• Academic experience will be considered

• Strong scientific understanding of formulation and process development in pharmaceutical related environment
• Ability to independently design experiments, analyze complex datasets, and recommend development strategies
• Strong organizational and communication skills with the ability to work and communicate cross-functionally
• General understanding of common LNP production process and analytical characterization techniques is desirable, prior experience running…