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mRNA Senior CMC Drug Product Leader Vaccine

Waltham, Massachusetts, Marcy-l'Étoile, France

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Overview

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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    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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    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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    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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Quote

"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."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

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 part of the Global Drug Product Development group within the mRNA Center of Excellence, you as a CMC DP development sub-team leader will represent mRNA-LNP DP (from bDP to finished product) on multiple CMC Project Teams and/or CMC platform teams.   In this role you are expected to work independently and to lead a cross-functional DP CMC sub-team with members from DP development, Raw Materials, Analytical Sciences, Quality, Regulatory, Devices, and Manufacturing etc to deliver DP development work packages from phase 1 through PPQ and submission.

KEY RESPONSIBILITIES

  • Lead cross-functional CMC DP sub-team(s) for complex mRNA-LNP based products and represents CMC Process Development & Industrialization function in multiple CMC project teams to enable definition of integrated CMC strategy and achieve the project objectives. 

  • Provide consolidated DP development technical work packages with timelines, resources and critical path activities to CMC core team for integration into overall CMC project plan

  • As a core team member of the CMC Platform Team, propose proactively drug substance platform innovations to be considered in the strategy set up (strategy owner: CMC platform lead)

  • Drive organizational goal of rapidly incorporating innovative advances in drug product platform, such as thermostable formulations, new lipids, etc, into CMC project progression to accelerate its adoption without impacting overall project timelines  

  • Partner with Research and CMC Development groups to establish developability with pillars such as stability, manufacturability, devicability to ensure new drug product can be produced using the platform process and ensure the development of new processes as required

  • 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 DS development leader to ensure coherence between DP and DS technical strategies

  • Lead the DP sub-team to ensure that drug product composition, process, and packaging definition is successfully transferred to GMP Manufacturing

  • Be the Drug Product Subject Matter Expert and utilize QbD framework to establish robust process and product control strategy.

  • Contribute to CMC part of the investigational and registration dossier and responses to agency questions

  • Create optimal conditions for full empowerment of DP sub team members and optimal cooperation with all stakeholders (Research, Manufacturing, Regulatory, Quality) to identify risks, mitigations and communicate to CMC core team

  • Contribute to DP manufacturing process and product platform innovation and engages externally in technical conferences and industry forums to shape platform for manufacturing and control strategies as well as CMC best practices for rapidly evolving LNP and associated DP platform

  • Prepare and communicate complex technical DP 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

COMPETENCIES / REQUIREMENTS

  • PhD > 8 years or Master’s Degree with > 10 years of experience in pharmaceutical industry, or equivalent

  • Experience in multi-site-operations and cultures, global projects 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. Fluency in French is preferred.

  • Cooperate transversally / Think strategically / Strive for results /Strong leaderships of transversal teams

  • Strong experience in vaccine or biologics development; mRNA & LNP experience preferred

  • Innovative mindset and ability to develop new technologies and new concepts

  • Strong knowledge of product and process development, cGMPs, and regulatory requirements

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

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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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