Job Title: Engineer-Scientist- Vaccines

Location: Waltham, MA

About the Job

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.

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:

• 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 preferred.

• 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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.