MRNA Analytical Development Scientist - Analytical Sciences

Job title:

mRNA Analytical Development Scientist - Analytical Sciences

• Location:
  
  Waltham, MA

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.

At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. The pandemic has sustainably transformed our industry, creating new opportunities and challenges. At Sanofi, we are convinced that accelerating the innovation of mRNA technology means better vaccine accessibility for all populations, faster than before.

For this reason, we are looking for bold, optimistic collaborators for our new team at the mRNA Center of Excellence. We are investing €400 million in this brand new centre, where 400 employees dedicated to this technology work.

This center of excellence is proof of our commitment to the development and acceleration of vaccination and research resources with the R&D, digital and CMC teams.

The future of Sanofi depends on your ambition, your commitment. Join.

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.

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.

• Develop advanced technology for biochemical and biophysical assay development, primarily focusing on LC-MS characterization, 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 under general supervision. Author method development and investigation reports.

• Support QC and/or CROs on investigations, deviations, and change control.

• Participate internal non-GMP and GMP lab set up and product release and stability testing.

• Provide training to junior team members.

• Compliant to Sanofi Quality standards and HSE policy. Participate in continuous improvement of laboratory safety and quality compliance.

• PhD or Master's degree (MSc) in Analytical Chemistry, Biochemistry, Biotechnology, or related sciences

• PhD holders:
  Minimum 1 year of pharma/biotech industry experience in analytical development and/or quality control

• MSc holders:
  Minimum 4 years of pharma/biotech industry experience in analytical development and/or quality control

• Expertise and extensive hands-on experience in the analyses and characterization of proteins, oligonucleotides, lipids and their degradants using LC-MS.

• Ability to perform complex method development and propose appropriate method improvement.

• Hands-on experience and comprehensive knowledge in other biochemical and biophysical techniques, including but not limited to LC (RP, IEX, SEC, HILIC), CGE, cIEF, spectroscopy, particle analysis, etc.

• Knowledge of nucleic acid/oligonucleotides chemistry and standard analytical methods of these molecules.

• Experienced in working with highly technical projects with reactivity.