COMPLETE mRNA - Associate Director, Drug Substance Platform Development - Vaccine - Waltham

mRNA Associate Director, Drug Substance Platform Development - Vaccine

In the race for the future of health– The Sanofi mRNA Center of Excellence (CoE)

At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. 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 for more people faster than before.

That’s why we’re looking for bold, optimistic world-changers to join the team at our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism for the future to Sanofi.

About the Opportunity

As an Associate Director within the Global CMC Drug Substance Development function, you will provide leadership to a group composed of scientists and engineers focusing on developing the next generation mRNA platform process within the mRNA CoE. The candidate will be responsible for designing and developing robust mRNA processes with stage appropriate control strategies from Phase 1 to approval.

KEY RESPONSIBILITIES FOR POSITION

About growing with us for winning with us

In this role you will….

• Build and lead a group of scientists and engineers to design and develop a scalable platform process for synthesizing and purifying mRNA drug substance

• Work with CMC Product Development & Industrialization team to develop processes that meet manufacturability requirements

• Develop plans to maintain, improve, and develop new competencies and assess resources (including personnel, facilities and equipment) necessary to meet current and future goals

• Coach and mentor direct reports to ensure continued development of platform competencies

• Establish criteria for measurable performance of the team and monitor with KPIs

• Deliver QbD based work packages to progress programs from pre-IND to approval including CQA definition, product and process design, characterization, and control strategy

• Ensure that platform is adhering to current regulatory practices and cGMP guidelines.

• Ensure safety of teams and compliance with good research practices, local and Global HSE/biosafety regulations

• Develop PAT for enhanced process monitoring and control.

• Actively participate and drive Sanofi’s position in conferences and scientific collaborations, with academia, industry, and regulatory agencies

COMPETENCIES / REQUIREMENTS FOR POSITION

About you

Qualifications/ Education & Work Experience

• MS with > 13 years or PhD with > 7+ years of experience developing mRNA drug substance development

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

• Experience leading multi-disciplinary teams

• Good oral communication, management, and interpersonal skills

• Results oriented, collaborative, decisive, strategic innovative thinker with passion for developing people

• Fluent in English

• Ability to travel domestic and international 10 – 20%

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.