mRNA - Associate Director, Drug Substance Platform Development - Vaccine
Sanofi
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Waltham, Massachusetts
Overview
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Success Profile
Do you have what it takes for a successful career with Sanofi?
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Culture: Play to Win
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Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Financial
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Culture
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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Work/Life Balance
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
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Responsibilities
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.
This job is no longer accepting applications
See open jobs at Sanofi.See open jobs similar to "mRNA - Associate Director, Drug Substance Platform Development - Vaccine" Mass Digital Health.