mRNA Analytical Development Senior Scientist

Sanofi; Waltham (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Sanofi Pasteur in Waltham, MA is seeking a Senior Scientist to advance analytical development for mRNA vaccine candidates. You will design and implement advanced biochemical and biophysical assays, support product release and stability studies, and work closely with bioprocess development and regulatory teams.

The role demands deep experience in CMC analytics, method development, and data interpretation, with opportunities to mentor junior scientists and contribute to continuous improvement of

Qualifications

• PhD or Master’s degree in Biochemistry, Biology, Cell Biology, Analytical Chemistry, Biotechnology or related sciences.
• Experience in pharmaceutical/biotech analytical development, including CMC aspects.
• Strong capability to develop and optimize analytical methods for nucleic-acid based products.

Responsibilities

• Develop advanced technology for biochemical, biophysical, and bioassay method development in support of mRNA vaccine process and product development, release, stability, and comparability studies.
• Collaborate with analytical leads supporting CMC activities.
• Write and review method documentation and characterization reports for regulatory filings.
• Ensure timely completion of assignments; independently design and execute complex experiments; author development and investigation reports.
• Manage assay testing at CROs if required; support investigations, deviations, and change control.
• Participate in non-GMP and GMP lab setup, product release and stability testing.
• Supervise and train junior scientists.
• Comply with Sanofi Quality standards and HSE policy; contribute to lab safety and quality improvements.

Skills

CMC analytical development

Complex method development

Regulatory documentation

Mentorship

Education

PhD in Biochemistry/related

Master's in Biochemistry/related

Tools

LC-MS

CGE

Job description

Job title: mRNA Analytical Development Senior Scientist

Location: Waltham, MA

About the job

In order to strengthen the Biochemical and Biophysical group in R&D Analytical Sciences Department, Sanofi Pasteur is looking for a skilled and highly motivated individual to develop novel methods and improve characterization of mRNA vaccines in development by working closely with the bioprocess development group.

Analytical Sciences Department has the overall responsibility to develop, qualify and validate robust analytical methods to support release and characterization testing of mRNA Drug Substances and Drug Products candidates in development.

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale - and shape the future of immunization.

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.

Main Responsibilities

• Develop advanced technology for biochemical, biophysical, and bioassay assay development in support of mRNA vaccine process and product development, product release, stability, and comparability study.
• Work with analytical leads supporting CMC activities.
• Write and review method documentation and characterization reports in support of 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 if required, support investigation, deviation, and change control.
• Participate internal non-GMP and GMP lab set up and product release and stability testing.
• Supervise and train junior scientists.
• Compliant to Sanofi Quality standards and HSE policy. Participate in continuous improvement of laboratory safety and quality compliance.

About you

Basic Qualifications

• PhD or Master's Degree in Biochemistry, Biology, Cell Biology, Analytical Chemistry, Biotechnology or related sciences.
• Ph.D. with a minimum of 3 years of experience in the pharmaceutical or biotechnology industry, or a Master's degree with a minimum of 6 years of experience in the pharmaceutical or biotechnology industry.
• Previous CMC analytical development experience.
• Expertise in LC (RP, IEX, SEC, HILIC) and one or more of the following techniques but not limited to CGE, spectroscopy, particle analysis.
• Ability to perform complex method development and propose appropriate method improvement suitable for CMC space.

Preferred

• Knowledge of nucleic acid/oligonucleotides chemistry and standard analytical methods of these molecules.
• LC-MS experience.
• Hands on experience in quality control laboratory environment is a plus.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.