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.

Sanofi Pasteur is looking for a skilled and highly motivated individual with expertise in physicochemical and biochemical methods development 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.

• 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, e.g., developing new bioassay methods for mRNA vaccine development, e.g., including cell-based western blot, sanger sequencing, high throughout sequencing, ELISA, qPCR, ddPCR, endotoxin and microbiology assays, binding assays, kinetic assays, etc.

• 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.

• Manage and direct the work of analysts and scientists.

• 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.

Leadership Skills

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.

• Being honest and treating people with respect and courtesy.

• Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.

• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Leading People

• Sanofi's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.

Leading the Business

• Sanofi's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Delivering to Customers

• Sanofi's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

• 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.

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

#GD-SP

#LI-SP

#mRNA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.