Principal Scientist, mRNA-tLNP Analytical Development

Principal Scientist, mRNA-tLNP Analytical Development Principal Scientist, mRNA-tLNP Analytical Development About Kernal Biologics, Inc. Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted lipid nanoparticle (tLNP) technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and Bristol Myers Squibb. Its leadership team brings a track record that includes three FDA-approved therapies and more than 120 patents. With support from leading investors—including Hummingbird Ventures, Amgen Ventures, Y Combinator, and HBM, Kernal Bio is transforming the future of cell therapy design and delivery. Job summary The Principal Scientist, Analytical Development at Kernal Biologics, will report to the Director of Drug Product Development and will lead the design, development, and execution of analytical methods to support the company’s mRNA platform for in vivo CAR-T programs. This role focuses on biophysical characterization and in vitro assay development for early-stage programs, with particular emphasis on antibody-targeted LNPs — including characterization of the antibody–lipid conjugates and the ligand-decorated particles they produce. The ideal candidate will bring deep expertise in analytical sciences, regulatory submissions, and fit-for-purpose method development and validation that support phase-appropriate requirements, along with a demonstrated track record of supporting product development. Responsibilities Lead the development and execution of bioanalytical methods for early-phase programs Serve as a subject matter expert inmRNA, LNP, and antibody-conjugated (targeted) LNPanalytical method development and data interpretation Collaborate cross-functionally to design and implement bioanalytical strategies for pre-clinical development programs Oversee and manage outsourced bioanalytical studies for mRNA and LNP platforms Develop and qualify methods to characterize antibody–lipid bioconjugates and targeted LNPs, including conjugation efficiency, antibody-to-particle ratio and surface ligand density, free/unconjugated antibody, conjugate identity and integrity, and antigen-binding activity Author and develop method protocols and analytical development plans aligned with program goals, regulatory requirements, and compliance standards Provide leadership to ensure GLP and GMP compliance across bioanalytical activities in both nonclinical and clinical studies Author and review bioanalytical sections of INDs and other regulatory submissions 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, 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 Experience with cell-based potency assay development, qualification, and troubleshooting is highly desirable Strong knowledge of CMC regulatory expectations and analytical requirements for global regulatory submissions Competitive 401(k) plan. Highly competitive healthcare coverage, including PPO and HMO (with HSA) options. Free parking, a monthly subway pass, or a subsidized commuter rail pass. Free Bluebikes membership. Flexible and health Spending account. Paid parental, family caregiver, and medical leave. Employer-paid life insurance coverage. On-site cafeteria. Competitive vacation and sick leave. Kernal Bio is committed to providing a diverse and inclusive work environment and equal employment opportunities to all employees and qualified applicants. We do not discriminate in employment practices based on race, color, national origin, age, sex, gender, sexual orientation, marital or veteran status, religion, disability, or any other status protected by applicable law. Kernal Bio provides reasonable accommodations to qualified individuals with known disabilities in accordance with applicable law. #J-18808-Ljbffr Kernal Biologics, Inc.