Scientist / Engineer

Sanofi • Waltham, MA

1d • $85,500 - $123,500 • Hybrid

About The Position

The USA-mRNA LNP Drug Product Team supports the Formulation and Process Development group in Waltham, Massachusetts, and reports to the DP Group Lab Team Lead. The role contributes to bringing new vaccines to market through formulation and process development for mRNA-containing lipid nanoparticle (LNP) drug products.

The Scientist / Engineer leads formulation optimization and process understanding for LNP formulations and production processes, working with a range of mRNAs and novel lipids. The position collaborates with Research to transfer and accelerate new LNP compositions into CMC development, designs and conducts small-scale formulation studies, develops initial processes, and compiles developability packages. It also supports stability studies, product characterization, troubleshooting, analytical method use, equipment installation, and communication of study findings.

Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related Chemistry science discipline, with 5 or more years of professional experience in formulation and/or process development; internships and co-ops may be considered where stated.
• Master's degree in Engineering, Pharmaceutical Sciences, or a related Chemistry 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 a related Chemistry science discipline, with at least 6 months of experience in formulation and/or process development. Academic experience will be considered.
• Strong scientific understanding of formulation and process development in a pharmaceutical-related environment.
• Ability to independently design experiments, analyze complex datasets, and recommend development strategies.
• Strong organizational and communication skills, including the ability to work and communicate cross-functionally.
• Desire to work in a fast-paced environment.
• Ability to be flexible and responsive to change, and to be a results-driven problem solver.

Nice To Haves

• General understanding of common LNP production processes and analytical characterization techniques.
• Prior experience running common LNP production and analytical characterization techniques.

Responsibilities

• Lead formulation optimization and/or process understanding for mRNA-containing LNP formulations and production processes involving different mRNAs and novel lipids.
• Work with the Research team to transfer and accelerate new LNP composition formulations into CMC development.
• Design and conduct small-scale, multi-component LNP formulation experiments to assess the developability of new formulations.
• Lead compilation of developability packages for new LNP formulations.
• Develop initial formulation processes for new LNP formulations.
• Design and arrange studies to assess the stability of new LNP formulations.
• Perform in-process drug product characterization.
• Perform complex and routine analytical methods to characterize new formulations and troubleshoot as needed.
• Coordinate, suggest, or introduce advanced LNP characterization analyses with the Analytical Sciences department.
• Support the Drug Product team in troubleshooting technical, formulation, and processing issues.
• Document study setup, results, and conclusions in an electronic lab notebook.
• Tabulate and analyze in-process and post-process characterization data.
• Summarize and present study progress, data, and analyses to scientific team members and larger group meetings.
• Support growth and expansion goals by setting up and installing characterization and process equipment in new laboratories.

Benefits

• Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs; eligibility may apply.
• Rewards package recognizing employee contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level