Head of mRNA Bioassay, Associate Director - Vaccines
Company: Sanofi
Location: Waltham
Posted on: March 20, 2026
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Job Description:
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, youll 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. Thats why were looking for bold,
optimistic world-changers to join our mRNA Center of Excellence.
Were 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: Were an R&D-driven, AI-powered biopharma company
committed to improving peoples 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 peoples 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. Act as advisor
to management and/or customers on advanced technical research
studies and applications. Manage and direct the work of analysts
and scientists. Act as role models for our fellow employees by
acting responsibly, fairly, and honestly in dealings and exercise
sound judgment in performing jobs. Motivate, inspire, build, and
retain highly effective team while managing for high performance
and developing others. About You Competencies / Requirements for
position: PhD or MSc/degree in Cell biology, Biology, Microbiology
or related sciences PhD with 8 years or MSc with at least 12 of
pharma/biotech industry experience, skilled in analytical
bioassays. Demonstrated people and project leadership skills
Ability to perform complex method development and propose
appropriate method improvement Knowledge of nucleic
acid/oligonucleotides chemistry and standard analytical methods of
these molecules Experience in various biological and bioanalytical
assays, including cell-based western blot, sanger sequencing, high
throughout sequencing, ELISA, qPCR, ddPCR, endotoxin and
microbiology assays, binding assays, kinetic assays, etc. Thorough
understanding of analytical technology and relevant statistical
methods. Proven capability of evaluating/developing new
technologies Excellent organizational skills Significant amount of
regulatory knowledge and guidance in cGMP, ICH, USP, etc. Able to
work independently and collaborate in teams, enthusiastic and
self-motivated 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
its 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. Sanofi Inc. and its U.S. affiliates
are Equal Opportunity and Affirmative Action employers committed to
a culturally diverse 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.
GD-SP LI-SP LI-Onsite mRNA vhd 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.
Keywords: Sanofi, Newton , Head of mRNA Bioassay, Associate Director - Vaccines, Science, Research & Development , Waltham, Massachusetts
