Scientist, mRNA Analytical Development
About The Position
NewLimit is a biotechnology company developing medicines to treat age-related diseases by reprogramming the epigenome and restoring regenerative potential in aged and diseased cells. It uses functional genomics, pooled perturbation screening, and machine learning to study epigenetic aging and disease. NewLimit is seeking a Scientist to establish and grow its mRNA analytical testing suite. The role leads development of analytical methods to characterize DNA templates and mRNAs, supporting mRNA process development as programs advance toward the clinic. This is a hands-on, lab-based role within Technical Operations that interfaces with Delivery Sciences, research teams, and external CDMOs. The Scientist will develop and establish methods for DNA template and mRNA drug-substance release and characterization; assess method performance and set phase-appropriate criteria; serve as the mRNA analytical lead for CMC program teams; conduct routine testing and investigate unexpected results; maintain instruments and assay materials; author protocols and technical reports; support method transfer and qualification at CDMOs; present results; and manage 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; alternatively, an M.S. with 5+ years or a 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, such as IP-RP-HPLC and SEC, capillary electrophoresis, and plate-based assays for impurity quantification, such as qPCR and 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 Haves
- 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.
Responsibilities
- Develop and establish analytical methods for DNA template and mRNA drug-substance release and characterization.
- Lead studies evaluating 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 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 outsourcing of advanced analytical techniques to CROs, as needed.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) with company match
- Paid parental leave
- 20 days of paid time off per year plus holidays
- Meals and snacks on-site
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
