mRNA Senior Drug Product Process Engineer

mRNA Senior Drug Product Process Engineer

Location: Marcy l’Étoile, France

Job type: Permanent, full time

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

About the job

As the mRNA – Drug Product (DP) Process Engineer, you’ll play a pivotal role in the Global Drug Product Development (GDPD) team within the mRNA Center of Excellence (CoE). Our GDPD team is at the forefront of innovation, responsible for crafting the Drug Product formulation and manufacturing processes that drive all our mRNA Vaccine programs from Phase 1 trials through to Phase 3 and commercialization.

You’ll collaborate closely with our US colleagues and work hand-in-hand with various departments, including Drug Substance Development, Analytical Sciences, Research, Process Industrialization, Global Process Harmonization & Tech Transfer, and cGMP Strategic Supply & Operations. Together, we strive to develop safe, stable, and patient-centric mRNA vaccines and therapeutic Drug Products, ensuring robust and reliable manufacturing processes.

Join us in our mission to revolutionize healthcare and make a lasting impact on global health!

Main responsibilities:

• Lead late-stage Drug Product process development activities and transfer to M&S in close collaboration with CoE groups (Industrialization, GMP operations, Technology Transfer, etc.) and CoE partners (M&S, Device, etc.).
• Support project plan definitions and provide scientific expertise and guidance to projects.
• As a Subject Matter Expert (SME) in Drug Product development; initiate, design and execute or supervise execution of the development of liquid and lyophilized mRNA-LNP drug product formulation and process.
• Supervise lab activities with technicians, internships, contractors and TPW, when appropriate. Proactively participate in laboratory organization and continuous improvement of WoW.
• Promote innovation, state of the art technologies, and propose strategies to improve the products. Maintain a consistent record of publications, patents, external presentations.
• Make scientific presentations and report project progress within mRNA CoE, with partners and in international forums.
• Proactively collaborate with other functions to meet projects and platform milestones.

About you

• Experience: Have contributed to the development and industrialization of several parenteral Drug Product. Ability to identify cutting-edge technologies and new directions.
• Soft and technical skills: Parenteral DP development, strong experience in QbD, pharmaceutical engineering, strong knowledge on different unit operations of drug product manufacturing (Lipid Nanoparticles manufacturing, TFF, Freeze/Thaw, mixing, filtration, aspetic filling, lyophilization), process modelling, digital tools. Good oral communication, proactive, organized, passionate about scientific progression, leadership, and interpersonal skills.
• Education: Chemistry, Biochemistry, Biotechnology, Pharmaceutical Engineering or related degree, PhD.
• Languages: French & English.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Explore new technologies to protect people and promote healthy communities.
• We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Join the team of bold, optimistic world-changers in our mRNA Center of Excellence. We’re investing €400m a year into the new Center, where we are focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research platform with R&D, digital, and CMC teams.

Pursue Progress. Discover Extraordinary.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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Location: Marcy-l'Étoile, FR

Posted Date: 11/12/2024