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"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

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Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

Sr. Principal Scientist, mRNA Synthesis Expert, L3-2

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!

About the Opportunity

As highly experienced IVT Expert in the Global DS Development team, you will support global mRNA strategy, process development, and innovation from early stage to commercial programs to:

ensure robustness and economics of IVT reaction processes
drive next generation IVT process development & support key strategic innovation initiatives
lead IVT reaction process control strategy

KEY RESPONSIBILITIES FOR POSITION

About growing with us for winning with us

In this role you will….

Provide strategic direction to all process development teams developing mRNA reaction processes to ensure scalable platform is established
Work transversally and proactively to make impactful contributions on R&D goals beyond group utilizing matrix management
Ensure the creation, evolution, and implementation of robust Process Control Strategy for reaction processes utilizing QbD framework and qualified scale down models
Advise on all aspects of IVT reactions, including purity improvements in synthesis, yield optimization, process robustness, PAT, scale-up, eco-design, and continuous manufacturing
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 mRNA Research and Data Science team to develop mechanistic and hybrid models to support efficient experimentation for process understanding and improvement
Partner with mRNA Science and Analytical Science team to identify mRNA related attributes and appropriate characterization methods to enable mRNA reaction performance characterization and improvements.
May lead technical project team with cross functional members
Participates in major troubleshooting task forces for complex deviations related to IVT and propose corrective actions
Has 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 synthesis
Supports CMC teams in preparing and/or reviewing dossier and responses to follow-up questions to post-approval change submissions
Provides 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

Molecular biology, biochemistry, engineering or related degree; PhD > 7+ years, MS and > 13y; BS and > 15 y
Expertise in mRNA IVT reactions, including enzymatica capping and enzymatic tailing reactions
Understanding enzymology and various modes of reactor design (batch, fed-batch, continuous) preferred)
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 substance development and industrialization 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.

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