Principal Scientist, mRNA-tLNP Analytical Development
On-siteBoston, Massachusetts, United States
Job Summary
Lead the design, development, and execution of bioanalytical methods for early-phase mRNA and LNP programs. Serve as a subject matter expert in antibody-targeted LNP characterization, including conjugation efficiency, ligand density, and antigen-binding activity. Collaborate cross-functionally to implement bioanalytical strategies for pre-clinical development while overseeing outsourced studies. Develop and qualify protocols for biophysical and biochemical techniques such as HPLC, LC-MS, and ELISA. Author regulatory sections for INDs and ensure GLP/GMP compliance across nonclinical and clinical activities. Report to the Director of Drug Product Development in Boston, MA.
Required Qualifications
- PhD (6+ years), MS (8+ years), or BS (12+ years) in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related field, with relevant industry experience
- Demonstrated expertise in developing analytical methods to test and characterize mRNA and LNP products, spanning both biophysical and biochemical techniques (particle size measurement, HPLC, LC-MS, CE, ELISA, qPCR, protein analysis, and in vitro potency assays)
- Strategic understanding of characterization approaches for mRNA, LNPs, biologics, monoclonal antibodies, and related modalities and bioconjugations
- Hands-on experience with targeted delivery systems and bioconjugation chemistry (e.g., maleimide/thiol, click, or site-specific conjugation), and with the analytics used to characterize them — SEC/HPLC, LC-MS, capillary electrophoresis, ELISA or other binding assays, and orthogonal particle characterization
- Experience providing technical oversight of CRO/CDMO analytical activities, including ICH-compliant stability programs and GMP testing
- Strong knowledge of CMC regulatory expectations and analytical requirements for global regulatory submissions
Desired Qualifications
- Experience with cell-based potency assay development, qualification, and troubleshooting is highly desirable
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