Mrna Scientist - Vaccine

The Engineer reports to Senior Scientist and is an integral part of GPH&TT team. This position offers
opportunities to focus on drug product process development, scale-up, GMP and Non-GMP manufacturing, regulatory and analytical support, validation, and data review for drug products.
The Scientist is responsible for assisting in the development and execution of scalable and robust processes for bulk drug product. This position will assist the GPH&TT Subject Matter Expert (SME) for process knowledge transfer of drug product to support cGMP manufacturing.
In this role, you will...

• Assist in the preparation of technical reports and presentations that support scale-up activities and process improvements
• Support and contribute to IND filings/regulatory documentation.
• Effectively communicate with cross functional teams like Analytical Development, R&D, Process Development, QA, Project Management, Regulatory Affairs and Legal teams.
• Troubleshoot process/analytical issues that occur during scale-ups and/or in production of drug product.
• Assist in project activities for the design and technology transfer of mRNA and nanoparticle manufacturing processes by contributing and reviewing of Batch Records/Master Production Records and SOPs.
• Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality
• Assist in the training of new associates and manufacturing technicians

About You

• A Bachelor’s degree and/or Master’s degree in Biomedical Engineering, Chemistry or Chemical engineering or related field with 4 -6 years of relevant experience is required.
• Ability to partner with CROs/CMOs.
• Demonstrated experience in process development, tech transfer, and/or scale-up to support the manufacturing of drug product is desired.
• Strong analytical and problem-solving skills.
• Excellent organizational and communication 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.
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