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mRNA - Senior Process Development Engineer - Drug Substance - Vaccine in Waltham, Massachusetts

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 an experienced Senior Engineer/Sr. Scientist in the Global Drug Substance Development group you will focus on development, optimization and scale-up of mRNA synthesis and purification processes with the ultimate goal of transferring at scale methods to either the internal or external manufacturing team for GMP manufacturing of mRNA drug substance. Experience with QbD approaches to ensure process robustness is essential.

In this role you will….

  • Develop scalable bench scale processes for mRNA drug substance material generation.

  • Use QbD principles to develop and improve scale down models for mRNA GMP drug substance production to support process understanding, CPP/KPP identification, and robustness studies (PAR and NOR validation) etc.

  • Responsible for applying scientific expertise and judgement to initiate, design, direct, and execute development studies to optimize and scale-up the mRNA process

  • Perform routine and complex analytical methods while working toward continual improvement

  • Train research associates and other team members

  • Analyze, interpret, and summarize results in reports and presentations

  • Proactively collaborate with other groups or sites in transfer of information, materials, and drug substance technology

  • Make decisions that require developing new options to solve moderately complex problems

  • Promote innovation, state of the art technologies, and propose strategies using publications to improve the products and processes

  • Demonstrate continuous growth in depth and breadth of personal scientific knowledge and understanding of strategic goals of group, team, and company

  • Support and contribute to IND filings/regulatory documentation.

About you

  • Biochemistry, engineering or related degree; PhD with 4 + years, MS with 6 + years, or BS with 8 + years of relevant industrial experience.Experience in large molecule drug substance development is preferred

  • Experience with enzyme reactions, mixing, depth filtration, tangential flow filtration, and chromatography

  • Previous work with mRNA (handling/isolation/quantification/characterization) is desired

  • Capable of working in a collaborative team environment both within group and on interdisciplinary teams

  • Desire to work in a fast-paced environment

  • Excellent organizational and communication skills

  • Strong analytical and problem-solving skills

  • Ability to work in a fast-paced environment

  • Good oral communication, management, and interpersonal 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.

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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