Head of mRNA Bioassay, Associate Director - Vaccines

Job title: Head of mRNA Bioassay, Associate Director - Vaccines

Location: Waltham, MA

About the job

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. 

In the race for the future of health – The Sanofi MRNA Center of Excellence (CoE)

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before. 

That’s why we’re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.   

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!  

About the Opportunity:

Sanofi Pasteur is seeking a dynamic and driven leader to head a 10+ person Bioassay group within the US mRNA analytical development, Analytical Sciences Department. In this role, you will spearhead the development and characterization of cutting-edge mRNA vaccine analytical methods, working in close collaboration with the Bioprocess Development team. You will play a pivotal role in advancing the qualification and validation of robust analytical methods that support the release and characterization of mRNA Drug Substances and Drug Products — directly contributing to the future of vaccine innovation.

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. Together, we chase the miracles of science to improve people’s lives. 

Main responsibilities:

• Lead the analytical development Bioassay team to support all analytical CMC activities for mRNA-based vaccine and drug development from Phase 1 to phase 3, including but not limit to process development, analytical release stability and characterization testing, CRO management, documentation management, and regulatory submission, etc. 

• Represent the Analytical Science group in CMC teams.

• Plan, initiate, and direct the overall scientific activities for new projects including new technological ideas; engage in bench laboratory work when appropriate.

• Set the scientific standards; develop and author complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.

• Stay current with regulatory guidance for vaccine and biological drug development and serves as a thoughtful leader and internal expert in dealing with regulatory commitments and responses.

• Initiate complex projects which have significant scientific risk and applies strong scientific risk assessment skills.

• Develop innovative and relevant solutions to extremely complex problems.

• Make critical contributions to scientific literature and conferences and is recognized internally and externally at national and international levels.

• Oversee analytical method development, qualification, validation, and transfer.

• Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process. 

• Function in a project leadership role, guiding the successful completion of major projects to meet the projected timeline.

• Participate in project strategy in consultation with supervisor and/or colleagues.

• Lead the analytical CMC section writing for regulatory submissions and responses.

• Work under consultative direction toward long-range goals and objectives.  Assignments are often self-initiated.

• Represent the organization in providing solutions to difficult technical issues associated with specific projects.

• Interact with senior external personnel on significant technical matters often requiring coordination between organizations.

• Serve as organization spokesperson on advanced projects and/or programs. <