About NewLimit
NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells. We leverage functional genomics, pooled perturbation screening, and machine learning models to unravel the biology of epigenetic aging and disease using experiments of unprecedented scale.
Position
We are seeking a Scientist to lead downstream process development for the mRNA Engineering team. In this role, you will design, optimize, and scale purification processes for mRNA drug substance.
This is a hands-on, lab-based role that spans program process development and platform engineering. It is ideal for a scientist who enjoys solving purification challenges and scaling processes in a dynamic, fast-paced environment.
What you'll do
As a member of our team, you will:
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
- Ph.D. in analytical chemistry, biochemistry, molecular biology, chemical engineering, or a related field with 0–3 years of relevant industry experience, or an M.S. with 5+ years 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 (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
Benefits
NewLimit offers generous benefits to ensure our team can focus on our mission:
- Health, dental, and vision insurance
- 401(k) with company match
- Paid parental leave
- Industry-leading paid time off (PTO) — 20 days/year for all employees + holidays
- Meals and snacks on-site
Salary Range: $120,000-155,000*. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO. Learn more at: https://www.newlimit.com/careers
*This compensation and benefits information is based on Company's good faith estimate as of the date of publication and may be modified in the future.