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Salary: USD 120,000 - 155,000 / annual
NewLimit is a biotechnology company developing medicines to treat age-related diseases by reprogramming the epigenome. The company uses functional genomics, pooled perturbation screening, and machine learning to understand epigenetic aging and disease.
You will lead downstream process development for the mRNA Engineering team, designing, optimizing, and scaling purification processes for mRNA drug substance. This is a hands-on, lab-based role 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
- 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
- Support process scale-up from bench to pilot scale
- 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:**
- Ph.D. in analytical chemistry, biochemistry, molecular biology, chemical engineering, or related field with 0–3 years of relevant industry experience; OR M.S. with 5+ years of relevant industry experience; OR 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 (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
