Job Title: Scientist, Analytical Development, mRNA and LNP
Job Number: 21202
Location: Cambridge, MA
Casebia Therapeutics is seeking an Analytical Development Scientist in the CMC group to lead development of assays to characterize and release mRNA and lipid nanoparticles (LNP) that will be used in Casebia’s novel gene editing therapies, including concentration, purity and activity. The assays will also be used to assess stability of preclinical batches. This Scientist will be part of an interdisciplinary team that is critical to Casebia’s success. He/she will collaborate with Process Sciences, mRNA manufacturing and formulation, and Quality Assurance groups to insure that drug substance and drug product meet all requirements.
- Develop, optimize and troubleshoot methods that measure the purity, structure and function of mRNA and LNP. Demonstrate high degree of accuracy, precision and specificity for the methods that are developed.
- Ensure that the methods are aligned with regulatory expectations and industry standards.
- Establish drug substance and drug product critical quality attributes and specifications.
- Design and carry out stability studies for mRNA in solution and formulated in lipid nanoparticles.
- Identify drug substance and drug product impurities to measure their impact on function.
- Write study protocols, technical reports and SOPs that support clinical development.
- Transfer assays within Casebia, to contract manufacturing organizations or to other service providers.
- Evaluate new technologies for characterization of nucleic acids and LNPs.
- Organize tasks and responsibilities such that individual goals and timelines are met.
- Ph.D. in molecular biology, biochemistry, chemistry or related discipline, with 1 -5 years of relevant industry experience.
- Experience using HPLC, capillary electrophoresis, structure-based methods, transfection, in vitro translation.
- Experience with RNA sequencing technology, include Sanger and Illumina MiSeq.
- Familiarity with research on lipid nanoparticles is a plus.
- Excellent verbal and written communication skills. Effective working on cross-disciplinary teams
- Exceptional attention to detail. Critical review of quantitative data.
- Knowledge of the regulatory requirements for characterization of biological therapeutics for pre-clinical and early phase clinical trials.