mRNA - Scientist, Drug Product Development

Job Title: mRNA - Scientist, Drug Product Development

Location : Waltham, MA

About the Job

As a Scientist within the Drug Product Platform and Early Clinical Development Team, you will focus on developing and optimizing the formulation and process of new mRNA lipid nanoparticles (LNPs) to support the development of new mRNA vaccines. This role supports early CMC development for the mRNA Center of Excellence and contributes to Sanofis goals of bringing innovative new mRNA vaccines to the market. This role will also work across teams and functions (CMC drug product development, Analytical Science, Research Formulation and Delivery, Drug Product Process leaders, CMC Regulatory, and Data Science) and involve providing scientific leadership, innovative ideas, troubleshooting, and guiding junior scientists.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Be an integrated part of the Drug Product Platform and Early Clinical Development Team and lead the effort in developability assessment, formulation optimization, and process understanding/development of new mRNA-LNPs to enable the development of new LNP platforms and support the progression of new vaccine projects from interfacing with Research to delivery information package to support Phase 1 clinical studies.

• Work closely with Research functions to transfer in and accelerate new LNP composition formulations into CMC development; Design and conduct small-scale multi-component LNP formulating experiments to assessment the developability of new LNP formulations; Coordinate the testing and characterization of new LNP formulations, including stability studies, within the Drug Product team and also with other functions, including Analytical Science and Research.

• Lead the compilation, information sharing, and documentation of the Developability package for new LNP formulations within the CMC and with the Research teams.

• Lead the process design, development, optimization and scale-up effort to support early CMC development of mRNA vaccines; This includes the design of phase-appropriate manufacturing process for tox batch manufacturing, conventional and accelerated Phase I clinical studies.

• Be the team representative on new vaccine Drug Product subteam(s) to support the drug product development and GMP readiness to support Phase I/II clinical studies.

• Author necessary formulation and process description documentation in the CMC workflow.

• Lead the technology transfer of drug product formulation and process to enable later stage GLP and GMP manufacturing.

• Lead process understanding initiatives to provide additional process design and scale up scientific insights to support process development and optimization across platform and new vaccine projects.

• Represent function in cross-functional and strategic teams engaged in novel mRNA vaccine development.

• Analyze, interpret, and summarize results in technical reports and presentations.

• Stay current with the literature on formulation and process development advancement related to LNPs and provide the team with suggestions for formulation/process design/scale-up/LNP characterization investigation and improvement.

• Provide training, technical oversight, execution directions, and mentorship to junior team members.

The duties of this role are conducted in a lab environment. Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage.

About You

Qualifications/ Education & work experience

• Earned Ph.D. in Pharmaceutical Science, Chemistry, Chemical Engineering, or related sciences with at least 1 year of relevant post-doc and/or industry experience.

• Strong preference for hands-on experience and knowledge in formulation and process development for LNPs or other lipid-based nanoparticle drug delivery systems.

• Formulation and analytical knowledge of nucleic acids, lipid biochemistry, formulation stability, and biotherapeutic drug product process development is essential.

• Deep knowledge of LNP structure and characterization is a preferred

• Knowledge in LNP characterization analytical tools, such as SEC, FFF-MALS, DLS, HPLC, RP-IP, AEX, AUC, microscopy, particle size tracking, and MFI, is a plus.

• Experience in Developability Assessment and Phase 1 clinical study support is a plus

• Desire to work in a fast-paced environment.

• Excellent organizational and communication skills

• Strong analytical and problem-solving skills

• A strong ability to communicate scientific topics in writing and presentations.

• The individual must work in a collaborative setting, and the ability to adhere to timelines is essential.

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.

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Better is out there. Better medications, better outcomes, better science. But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK .