mRNA Analytical Development Senior Scientist
About The Position
Sanofi Pasteur is seeking a skilled, motivated scientist to strengthen 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. The department develops, qualifies, and validates robust analytical methods supporting release and characterization testing of mRNA drug substances and drug product candidates. The position develops biochemical, biophysical, and bioassay methods for mRNA vaccine process and product development, release, stability, and comparability studies. It works with analytical leads on CMC activities; prepares method documentation and characterization reports for regulatory filings; designs and executes complex experiments; and authors method-development and investigation reports. The scientist may manage CRO assay testing and support investigations, deviations, and change controls. The role also participates in non-GMP and GMP laboratory setup, release and stability testing, and the supervision and training of junior scientists. Compliance with Sanofi quality standards and HSE policy, and continuous improvement in laboratory safety and quality, are expected.
Requirements
- PhD or Master's degree in Biochemistry, Biology, Cell Biology, Analytical Chemistry, Biotechnology, or a related science.
- For PhD holders, at least 3 years of experience in the pharmaceutical or biotechnology industry; for Master's degree holders, at least 6 years of such experience.
- Previous CMC analytical development experience.
- Expertise in liquid chromatography (RP, IEX, SEC, or HILIC) and one or more additional techniques, including but not limited to CGE, spectroscopy, or particle analysis.
- Ability to perform complex method development and propose suitable method improvements for the CMC space.
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 to support 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 and product release and stability testing.
- Supervise and train junior scientists.
- Comply with Sanofi quality standards and HSE policy, and participate in continuous improvement of 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.
- A rewards package; specific details are not provided.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
