Scientist/Senior Scientist, mRNA Process Development

Position Overview

The Scientist/Senior Scientist, mRNA Process Development will lead the development and optimization of scalable mRNA manufacturing processes for preclinical and clinical applications. The successful candidate will establish and optimize automated, high-throughput workflows for multiscale production of DNA templates (e.g., plasmid linearization, PCR amplification, purification) and mRNA (e.g., in vitro transcription (IVT), enzymatic processing, purification, analytical characterization, and formulation) leveraging liquid handling systems, chromatography platforms, and microfluidic technologies to support scalable and reproducible manufacturing. This role involves hands-on bench work, process innovation, and cross-functional collaboration to advance mRNA-based therapeutics across diverse therapeutic areas.

Key Responsibilities

• Design and generate high-quality DNA templates for IVT process, including plasmid linearization, PCR amplification, and synthetic gene fragment assembly, ensuring optimal transcription efficiency and fidelity.
• Establish and maintain robust workflows for DNA template preparation, incorporating quality control measures such as gel electrophoresis, spectrophotometry, and endotoxin removal to support scalable mRNA manufacturing.
• Develop and optimize in vitro transcription (IVT) processes for multiscale mRNA synthesis, including enzymatic reactions, and yield enhancement strategies.
• Establish purification workflows for mRNA using chromatography, filtration, and enzymatic treatments to ensure high purity and integrity.
• Characterize mRNA drug substance using advanced analytical techniques (e.g., capillary electrophoresis, UV spectroscopy, LC-MS, bioanalyzers, qPCR).
• Source, evaluate, and select critical raw materials (e.g., capping reagents, enzymes, nucleotides, buffers) required for DNA template preparation and mRNA synthesis, ensuring quality, compatibility, and scalability for research and manufacturing workflows.
• Develop and maintain SOPs for mRNA synthesis, purification, and analytical characterization to ensure high quality, reproducibility, and regulatory compliance.
• Collaborate with formulation and delivery team to integrate mRNA constructs into appropriate delivery systems for in vitro and in vivo studies.
• Maintain accurate records using LIMS/ELN systems to support data integrity and reproducibility.
• Serve as the technical lead in cross-functional teams, driving mRNA process development from early-stage research to IND-enabling studies.
• Contribute to NATi’s intellectual property portfolio through innovation in mRNA chemistry, process design, and analytical technologies.
• Prepare technical reports, presentations, and documentation to support internal decision-making and external regulatory submissions.
• Mentor junior scientists and research associates as the mRNA platform expands.

Qualifications & Experience

• Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, or a related field.
• Minimum of +4 (Scientist) or +8 (Senior Scientist) years of hands-on experience in mRNA process development in pharmaceutical or biotechnology settings.
• Hands-on experience in DNA template design and preparation (e.g., plasmid linearization, PCR amplification), IVT reaction optimization, mRNA purification, and operation of associated equipment.
• Experience with analytical tools for RNA characterization (e.g., HPLC, LC-MS, CE, UV, qPCR, gel electrophoresis).
• Experience with automated platforms for nucleic acid production and purification is highly desirable.
• Experience with emerging mRNA constructs such as circular RNA, self-amplifying RNA (saRNA), and other next-generation RNA formats is highly desirable.
• Proven track record in mRNA-based therapeutic development, demonstrated by contribution to publications, patents, regulatory filings, or other public disclosures.
• Experience working in GMP or IND-enabling environments is a plus.
• Prior experience in development of mRNA-based therapeutics for infectious diseases, immunity, or genetic disorders is a plus.

Apply Here: Career – Agency for Science, Technology and Research