mRNA - Head of CMC DS Leaders and Experts - Vaccine
mRNA - Head of CMC DS Leaders and Experts - Vaccine
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mRNA – Head of CMC DS Leaders and Experts (M/F)
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
The mRNA Head of CMC DS Development Leaders and Experts must be a seasoned CMC leader with diverse experience, including
drug development experience required to manage a team of CMC DS Leaders driving all aspects of drug substance development from research to IND filing
technical process development experience to managed experts in enzymes, mRNA reactions, and purification
KEY RESPONSIBILITIES FOR POSITION
About growing with us for winning with us
In this role you will….
Lead a team of CMC DS Development Leaders (both product and platform projects) and scientific experts in the disciplines of enzymes, mRNA reactions, and purification.
Guide DS Development Leaders to provide consolidated DS development technical work packages with timelines, resources, and critical path activities to CMC core team for integration into overall CMC project plan from research to regulatory filing
Drive organizational goal of rapidly incorporating innovative advances in drug substance and process platform (such as ultra-pure mRNA, continuous manufacturing, and PAT) into CMC project progression to accelerate its adoption without impacting overall project timelines.
Partner with CoE’s DS Development Managers, Research and Biomarkers experts, and DS Development community to ensure the manufacturability of new mRNA sequence using the platform process.
Work with your team to proactively propose strategic drug substance platform innovations and work with the DS Development Managers to implement into the platform and projects.
Collaborate with Analytical Sciences group to ensure existing platform methods are suitable for new constructs and to develop new, innovative methods as required in support of phase appropriate control strategies (process, raw material, analytical) and comparability strategies.
Collaborate with DP Development Leaders to ensure coherence between DS and DP technical strategies.
Lead Drug Substance Experts and utilize QbD framework to establish robust process and product control strategy.
Create optimal conditions for full empowerment of DS subteam members and optimal cooperation with all stakeholders (Research, Analytical Sciences, Manufacturing, Regulatory, and Quality) to identify risks, mitigations and communicate to CMC core team.
Engage externally in technical conferences and industry forums to shape platform for manufacturing and control strategies as well as CMC best practices for rapidly evolving mRNA platform.
Prepare and communicate complex technical DS topics associated with specific CMC project team to a variety of stakeholders in mRNA center and outside.
Work globally with groups and colleagues in the United States and France
As needed, directly lead cross-functional CMC DS subteam(s) for complex mRNA-LNP based products and represents CMC Process Development & Industrialization function in multiple CMC project teams to execute the CMC strategy and achieve the project objectives.
COMPETENCIES / REQUIREMENTS FOR POSITION
Qualifications/Education & Work Experience
PhD > 12 years or Master’s Degree with > 15 years of experience in pharmaceutical industry, or equivalent
Experience in multi-site-operations and cultures, global projects, direct and matrix management
A strong relationship builder at all levels both internally and externally and able to lead a matrix team
Fluency in English is required.
Cooperate transversally / Think strategically / Strive for results /Strong leaderships of transversal teams
Strong experience in vaccine or biologics development from early stage to product approval; mRNA experience preferred
Innovative mindset and ability to develop new technologies and new concepts
Strong knowledge of product and process development, cGMPs, and regulatory requirements across all stages of product development
Problem-solver and decision-maker
Excellent interpersonal and communications 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.
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.