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. 

• 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 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. 

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. 

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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.