Massachusetts Jobs

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.

Why choose us?

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

#LI-EUR

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)