mRNA – Sr. Principal Scientist, Lipid Nanoparticle (LNP) Formulation and Process Development

mRNA – Sr. Principal Scientist, Lipid Nanoparticle (LNP) Formulation and Process Development

Primary location – Waltham, MA

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!

INTRO ABOUT THE POSITION

About the Opportunity

As highly experienced LNP development scientist in the Global DP Development team, you will support global mRNA-LNP strategy, formulation & process development, and innovation from early stage to commercial programs. You will lead a team of scientists and engineers to ensure development of stable and LNPs that form the basis of thermostable mRNA-LNP drug products.

KEY RESPONSIBILITIES FOR POSITION

About growing with us for winning with us

In this role you will….

• Provide direct supervision and strategic direction to your team of scientists and engineers engaged in LNP development for clinical and commercial use

• Partner within DP development function with the overarching goal of developing liquid and dried thermostable mRNA-LNP drug products

• Work transversally and proactively to make impactful contributions on R&D goals beyond group

• Ensure the creation, evolution, and implementation of robust Control Strategy for LNPs utilizing QbD framework and appropriate scale down models

• Responsible for applying scientific expertise and judgement to initiate, design, direct and execute experiments and/or studies in support of development project goals, including guidance on experimental design utilizing DOE   

• Partner with Research Formulation and Data Science team to develop mechanistic and hybrid models to support efficient experimentation for product understanding and improvement

• Partner with Analytical Science team to identify mRNA related attributes and appropriate characterization methods for LNPs

• May lead technical project team with cross functional members

• Participate in major troubleshooting task forces for complex deviations related to LNPs 

• Have a growing reputation in the external scientific community based on productive scientific collaborations and active participation in conferences

• Support Intellectual Property objectives related to mRNA-LNP formulation and process

• Support CMC teams in preparing and/or reviewing dossier and responses to follow-up questions to post-approval change submissions

• Provide technical mentorship to upcoming talent in network and knowledge management/transfer 

• Work globally with groups and colleagues in the United States and France

• May participate as technical expert in business development due diligence supporting activities

COMPETENCIES/REQUIREMENTS FOR POSITION

About you

Qualifications/Education & Work Experience

• Biochemistry, engineering, pharmaceutical science or related degree; PhD > 7+ years, MS and > 13y

• Demonstrated expertise in mRNA-LNP formulation and process development

• Deep understanding of LNP structure and function, impact of LNP composition and process on immunogenicity, reactogenicity, and stability

• Understanding of complex R&D landscapes globally, ability to identify cutting-edge technologies and new directions, strong academic and biotech/pharma scientific networks

• Experience with QbD approach in drug product development strongly preferred

• Desire to work in a fast-paced environment

• Good oral communication, management, and interpersonal skills.

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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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.