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mRNA - Manager, External Manufacturing - Vaccine

Waltham, Massachusetts



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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."

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


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 Manager of External Manufacturing will be responsible for project management functions for the Technical Operations team, which includes helping to coordinate and drive activities for Sanofi’s mRNA Center of Excellence programs via third party CDMOs for Phase III and commercial launch of drug candidates and custom raw material CMOs. The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences / pharmaceutical / biotechnology industry. This role is part of a team-focused on development and manufacturing of novel mRNA vaccines.

Key aspects of this position include ensuring that our manufacturing processes and equipment are fit for purpose and that Drug Substance (DS), bulk Drug Product (bDP), and Finished Drug Product (FDP) and custom raw materials are manufactured and released through our CMO partners according to phase-appropriate GMPs as needed to meet clinical demand and commercial launch. Assistance with the tech transfer activities to ensure accurate translation of the process requirements into CMO Batch Records and SOPs will also be a focus.

Additional responsibilities will include collaborating with the tech transfer and process scale-up and working with the Process and Analytical Development and Quality Assurance functional groups to provide manufacturing and technical support facilitating CMO issue resolution, deviation / investigation closure, and product disposition.

In this role, you will..

  • Act as a primary or secondary liaison with CMOs to ensure product manufacturing meets demand requirements for drug substance (DS), bulk drug product (bDP), and finished drug product (FDP).  This will include communicating production demand planning to the CMO, Person-in-Plant activities, executed batch record review and issue resolution, deviation / investigation support and closure, and support of final product disposition as needed by QA.

  • Manage CMC aspects of both internal and external projects.  Organize and facilitate Gantt charts and manage timelines, particularly critical path items. Develop and maintain project charters, RACI matrices, and resource trackers.

  • Lead internal project team through issuance of meeting agendas, facilitating regularly scheduled meetings, issuance of minutes, tracking action items, etc. Control and track information exchange with other internal groups and external collaborators as needed.

  • Assisting with the tech transfer activities from Sanofi to CMO partners.  This includes ensuring accuracy of the process description, review of Master Batch Records and SOPs for alignment with the process description.

  • Act as a liaison with Supply Chain to ensure raw material supplies meet demand needs for drug substance, bulk drug product, and fill/finish manufacturing operations.

  • Partner with our technical departments to help ensure success of tech transfer activities from Sanofi to CRO/CMO partners. This will include review and approval of raw material / consumables procurement plans, and coordination with Analytical Development on analytical method transfer / qualification / validation.

  • Work with Process Engineering to provide support for tech transfer and process scale-up activities.  Assistance with hands-on execution of process development activities and demonstration batches may also be required.

  • Prepare campaign summary reports as required.

  • Organize, evaluate, and communicate data in an effective and scientific manner.

About you

  • 8+ years of relevant manufacturing, process development or quality assurance experience in the biopharmaceutical industry.

  • BS / MS in Engineering (preferred) or Life Sciences. Advanced degree in business or management is not required but preferred.

  • Experience in technical/process development and process/technology transfer as well as GMP manufacturing, focused on biologics or ATMPs is a plus.

  • Expertise with all aspects of MS Office including Visio and MS Project.

  • Experience in CMO management preferred.

  • Demonstrated success in managing multiple projects effectively.

  • Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.

  • Excellent communication skills and ability to provide clear, concise descriptions of CMC/technical tasks, issues, schedule challenges, and proposed solutions.

  • Results-oriented and demonstrated focus on achieving business results. Experience with project team meetings, cross-functional communication, supporting decision making, influencing outcomes, and ensuring alignment among internal and external stakeholders is preferred.

  • Familiar with current issues and regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production is a plus.

  • Ability to travel (domestic and international) ~15% of time, particularly when production campaigns are being done.

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.  



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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