mRNA -Engineer - Scientist - Vaccine

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:

The Engineer/Scientist reports to Senior/Principle Scientist and is an integral part of Process Harmonization and Tech Transfer team. This position offers opportunities to primarily focus on process development, tech transfer, and manufacturing of drug product for clinical and non-clinical use. The Engineer/Scientist is responsible for assisting in all activities related to the development, scale-up and transfer of both bulk and finished drug product manufacturing process for mRNA encapsulated lipid nanoparticles.

In this role, you will...

• Assist in process development and improvement of mRNA LNPs drug product manufacturing process. Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality

• Lead mfg. of scale down batches of drug product to support non-clinical studies.

• Act as liaison between the clinical production team and process development team to ensure the process being developed is feasible for cGMP manufacturing.

• Work closely with clinical production team for selection and procurement of new materials, single use consumables, and equipments required for bulk drug product manufacturing.

• Serve as drug product technical subject matter expertise (SME) in project meetings and work closely with internal/external CMOs for timely transfer of manufacturing process.

• Support technical activities related to the fill finish operations for drug product such as freezing/thawing process, container closure selection, sterile filter selection and validation, filtration parameters, stability studies etc.

• Author documents and technical reports required for tech transfer of drug product process.

• Train and oversee manufacturing operations for bulk and finished drug product to support cGMP manufacturing.

• Assist in reviewing of batch records, SOPs, change control, deviations, gap assessments, stability protocols, and other technical documents.

• Effectively communicate with cross functional teams like Analytical Development, R&D, Process Development, QA, Project Management, Regulatory Affairs and Legal teams.

• Support and contribute to IND filings/regulatory documentation.

• Assist in the training of new associates and manufacturing technicians

• Lead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables

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.

• Demonstrated experience in cGMP manufacturing, process development, tech transfer, fill finish operations, and scale-up to support the manufacturing of drug product is preferred.

• Experience in aseptic fill finish operations of parenteral drug products would be a plus.

• Knowledge of mRNA and lipid nanoparticles manufacturing process is preferred.

• Ability to partner with CMOs

• Excellent organizational and communication skills.

• Strong analytical and problem-solving skills.

• Technical writing skills required

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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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.