cGMP Strategy and Technology Enablement Associate - VIE Contract

cGMP Strategy and Technology Enablement Associate - VIE Contract

• Location: United States of America, Waltham
• Target start date: 01/06/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As cGMP Strategy and Technology Enablement Associate in our Development team, you will spend your time gaining valuable skills, experience and insights at our state-of-the-art messenger ribonucleic acid (mRNA) Center of Excellence in Waltham. It’s a fantastic opportunity to see next-generation technology up close while working alongside some of the best in the industry.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring 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.

Main responsibilities:

• Project Management Responsibilities: Manage tasks related to contract management, procurement, purchase order processes, and technology enablement. Key duties include scheduling meetings, preparing and distributing agendas, facilitating discussions, and documenting and issuing detailed meeting minutes.
• Current Good Manufacturing Practice (cGMP) Footprint Maintenance Duties: Collaborate with Strategic Outsourcing, Process Development, Supply Chain, Quality Assurance, and Analytical Sciences to develop and maintain a comprehensive, up-to-date overview of the mRNA Vaccines clinical manufacturing footprint. This includes current and future capacities and capabilities for the production, testing, and release of clinical materials on a global scale.
• Technical Database Support: Support the development and maintenance of the technical database for process and analytical instruments and methods related to the clinical production of plasmid Deoxyribonucleic acid (DNA), mRNA drug substance, Lipid nanoparticles (LNP) bulk drug product, and finished drug product vials. This database serves as a key resource for the cGMP Footprint capacities and capabilities review process and facilitates the creation of standardized Request for Proposal (RFP) documents to streamline proposals for potential contract manufacturing, development, and testing sites.
• Process and Analytical Technology Enablement Support: Assist with process and analytical transfer activities to newly enabled external and internal supply chain components prior to hand off to relevant Sanofi accountable business unit. Activities include planning, coordination and execution of technology transfer protocols to ensure seamless integration and compliance with regulatory requirements, and successful implementation at the receiving site.
• Vendors Database Support: Support the ongoing maintenance of the Vendors Database used to store partner literature, meeting minutes and contracts.

About you

Experience:

• 1+ years of experience in a similar role.

Soft and Technical skills:

• Basic knowledge of drug development and manufacturing processes, such as formulation, production, and quality assurance.
• Familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), or other regulatory standards like Food and Drug Administration (FDA) or European Medicines Agency (EMA) guidelines.
• Ability to interpret scientific data, perform basic statistical analysis, and utilize tools such as Excel.
• Strong focus on accuracy and compliance, especially in documentation and following protocols.
• Ability to draft clear documents, effectively communicate within a team, and present findings or ideas succinctly.
• Experience working in collaborative environments, such as internships, research projects, or cross-functional teams.
• Demonstrated ability to troubleshoot and resolve basic technical or procedural issues.
• Willingness to learn new processes, tools, and technologies in a fast-paced and regulated environment.
• Exposure to organizing tasks, meeting deadlines, and prioritizing work in academic or internship settings.

Education:

• Bachelor’s or Master’s degree in Business or Technical Discipline.

Languages:

• Fluent English
• Fluent French would be a plus.