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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. They use functional genomics, pooled perturbation screening, and machine learning to understand epigenetic aging and disease.
You will establish and grow NewLimit's mRNA analytical testing suite as a hands-on, lab-based scientist within Technical Operations. This role interfaces with Delivery Sciences, research teams, and external CDMOs, and is ideal for an analytical scientist who enjoys building from the ground up and expanding their scope.
Key responsibilities:
**Build the analytical suite:**
- Develop and establish analytical methods for DNA template and mRNA drug substance release and characterization
- Lead studies to evaluate method robustness, specificity, sensitivity, precision, accuracy, and linearity; set phase-appropriate performance criteria
- Act as the mRNA analytical lead for CMC program teams
- Evaluate emerging analytical technologies to expand internal testing capabilities
**Run and maintain assays:**
- Perform routine testing of DNA templates and mRNA materials to support process development and research programs
- Investigate unexpected impurities, degradation, and atypical results
- Maintain instruments, reference standards, assay controls, and critical reagents
**Documentation and collaboration:**
- Author method protocols and technical development reports
- Support method transfer and qualification at CDMOs
- Present experiment results at team meetings
- Manage outsourcing of advanced analytical techniques to CROs as needed
**Requirements:**
- Ph.D. in analytical chemistry, biochemistry, molecular biology, chemical engineering, or related field with 0–3 years relevant industry experience; OR M.S. with 5+ years relevant industry experience; OR B.S. with 7+ years relevant industry experience
- Experience with assay development and qualification across a broad range of mRNA analytical methods
- Hands-on experience executing and troubleshooting HPLC separations (e.g., IP-RP-HPLC, SEC), capillary electrophoresis, and plate-based assays for impurity quantification (e.g., qPCR, ELISA)
- 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:**
- Understanding of analytical method lifecycle and phase-appropriate method qualification
- Experience with sequencing workflows and data analysis (Sanger, Oxford Nanopore Technologies)
- Experience developing cell-based potency assays
- Experience with LC-MS assays for evaluating poly(A) tail length and capping efficiency
- Experience transferring analytical methods to CDMOs
