Scientist, mRNA Analytical Development

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 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.

What you'll do

As a member of our team, you will:

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, 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

Run and maintain the 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 the outsourcing of advanced analytical techniques to CROs, as needed

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
• 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 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

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.