Scientist, mRNA Analytical Development

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.

We are seeking a Scientist to establish and grow NewLimit's mRNA analytical testing suite. In this role, you will lead the development of analytical methods to characterize our DNA templates and mRNAs. The assays you build will drive mRNA process development efforts as our programs advance toward the clinic.

This is a hands-on, lab-based role within Technical Operations that will interface with Delivery Sciences, research teams, and external CDMOs. It is ideal for an analytical scientist who enjoys building from the ground up and wants to expand their scope.

As a member of our team, you will:

• 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, and set phase-appropriate performance criteria
• Act as the mRNA analytical lead for CMC program teams
• Evaluate emerging analytical technologies to expand our internal testing capabilities

• 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

• Author method protocols and technical development reports
• Support method transfer and qualification at CDMOs
• Present experiment results at team meetings
• Manage the outsourcing of advanced analytical techniques to CROs, as needed

• 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
• 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

• Understanding of the analytical method lifecycle and phase-appropriate method qualification
• Experience with sequencing workflows and data analysis, including Sanger and 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