mRNA Analytical Development Senior Scientist

Sanofi • Waltham, MA

1d • Hybrid

About The Position

Sanofi Pasteur is seeking a skilled and motivated scientist to join the Biochemical and Biophysical group in the R&D Analytical Sciences Department. The role develops novel methods and improves characterization of mRNA vaccines in development, working closely with the bioprocess development group. Analytical Sciences is responsible for developing, qualifying, and validating robust methods to support release and characterization testing of mRNA drug substances and drug product candidates.

The position develops biochemical, biophysical, and bioassay methods in support of mRNA vaccine process and product development, release, stability, and comparability studies. It also supports CMC activities, regulatory documentation, laboratory operations, and the training of junior scientists. The role is based in Waltham, Massachusetts.

Requirements

• Ph.D. with at least 3 years of experience, or a master's degree with at least 6 years of experience, in the pharmaceutical or biotechnology industry.
• Ph.D. or master's degree in biochemistry, biology, cell biology, analytical chemistry, biotechnology, or a related science.
• Previous CMC analytical development experience.
• Expertise in liquid chromatography, including RP, IEX, SEC, or HILIC, and one or more techniques such as CGE, spectroscopy, or particle analysis.
• Ability to perform complex method development and propose appropriate improvements suitable for the CMC environment.

Nice To Haves

• Knowledge of nucleic acid or oligonucleotide chemistry and standard analytical methods for these molecules.
• LC-MS experience.
• Hands-on experience in a quality control laboratory environment.

Responsibilities

• Develop advanced biochemical, biophysical, and bioassay technologies for mRNA vaccine process and product development, product release, stability, and comparability studies.
• Work with analytical leads supporting CMC activities.
• Write and review method documentation and characterization reports for regulatory filings.
• Ensure timely completion of assignments and deliverables.
• Independently design and execute complex experiments.
• Author method development and investigation reports.
• Manage assay testing at CROs when required and support investigations, deviations, and change controls.
• Participate in internal non-GMP and GMP laboratory setup, product release testing, and stability testing.
• Supervise and train junior scientists.
• Comply with Sanofi quality standards and HSE policy.
• Contribute to continuous improvement in laboratory safety and quality compliance.

Benefits

• Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employee benefit programs may be available.
• Rewards package that recognizes employee contributions.

What This Job Offers

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