Principal Scientist, Upstream - RNA

Role Summary

Principal Scientist, Upstream - RNA, laboratory-based role in Cambridge, MA focusing on delivering new mRNA vaccine candidates from development to clinical manufacturing within the NAV CoE, contributing to current and next-generation mRNA vaccine platforms.

Responsibilities

• Autonomously design, execute, and analyze experiments to develop and optimize RNA in-vitro transcription processes to translate into the mRNA platform and continuously evolve it, ensuring phase-appropriate and scalable processes, as part of the overall platform development strategy.
• Lead transversally process development activities of the upstream team and any additional initiatives that may arise.
• Collaborate across BE and US-based DS teams, Analytical R&D, GMP teams, and other groups in an agile, communicative way.
• Drive innovative solutions and meet project milestones.
• Stay up to date on industry trends and emerging technologies in downstream processing, contributing to continuous improvement initiatives.

Qualifications

• Required: MS or PhD in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering, or related field.
• Required: Experience with RNA biology and mechanisms of eukaryotic translation.
• Required: 5+ years of industry experience in process development for large biomolecules, preferably mRNA and pDNA, with hands-on experience in mRNA synthesis workflows.
• Required: Experience in overall process development and analytical development activities required for CMC support.

Preferred Qualifications

• Experience with Quality by Design.
• Experience with DOE studies, process improvements, and advancements including parameter optimization, scale-up, and process window determination.
• Knowledge of large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.
• Experience and understanding in nucleic acid analytical technologies.