Scientist, mRNA Downstream Purification

About the Role

NewLimit is a biotechnology company developing medicines to treat age-related diseases. We are seeking a Scientist to lead downstream process development for the mRNA Engineering team. This is a hands-on, lab-based role focused on designing, optimizing, and scaling purification processes for mRNA drug substance, spanning program process development and platform engineering.

Key Responsibilities

• Develop downstream purification processes:
• Design, execute, and analyze process development studies for mRNA purification.
• Act as the downstream lead for CMC program teams.
• Help design and implement automated downstream workflows for high-throughput purification of research-grade mRNA.
• Support execution of research-grade mRNA production runs for discovery and preclinical studies, as needed.
• Support process scale-up from bench to pilot scale, as needed.
• Evaluate emerging purification technologies and chromatography resins.
• Support tech transfer and CDMO manufacturing:
• Perform tech transfer of downstream processes to CDMOs.
• Act as person in plant during CDMO manufacturing runs.
• Support process troubleshooting and deviation investigations at CDMOs.
• Documentation and collaboration:
• Maintain organized experimental records in Electronic Lab Notebooks.
• Author development SOPs and technical development reports.
• Present experiment results at team meetings.

Requirements & Tech Stack

• Ph.D. in analytical chemistry, biochemistry, molecular biology, chemical engineering, or a related field with 0–3 years of relevant industry experience.
• M.S. with 5+ years of relevant industry experience.
• B.S. with 7+ years of relevant industry experience.
• Hands-on experience developing downstream purification processes for nucleic acids or other biologics.
• Hands-on experience with tangential flow filtration (TFF).
• Experience operating ÄKTA chromatography systems.
• Ability to independently design, execute, and troubleshoot experiments.
• Ability to analyze and present complex data sets.
• Strong technical writing skills.
• Excellent communication and organizational skills.

Nice to Have

• Experience with traditional nucleic acid purification methods (e.g., desalting, precipitation, size-exclusion).
• Experience with plasmid DNA purification.
• Experience with Design of Experiments (DoE) and statistical data analysis.
• Experience implementing automated or high-throughput purification workflows.
• Experience with process transfer to CDMOs.
• General understanding of cGMP and phase-appropriate process development.
• Familiarity with mRNA analytics such as HPLC, CGE, and dsRNA ELISA.