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Kernal Biologics is a venture-backed therapeutics company developing in vivo CAR-T therapies using AI-designed mRNA and targeted lipid nanoparticle (tLNP) technology for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and Bristol Myers Squibb, with backing from Hummingbird Ventures, Amgen Ventures, Y Combinator, and HBM.
As Principal Scientist for mRNA-tLNP Analytical Development, you will report to the Director of Drug Product Development and lead the design, development, and execution of analytical methods supporting the company's mRNA platform for in vivo CAR-T programs. Your focus will be on biophysical characterization and in vitro assay development for early-stage programs, with particular emphasis on antibody-targeted LNPs.
Key responsibilities include:
- Lead bioanalytical method development and execution for early-phase programs
- Serve as subject matter expert in mRNA, LNP, and antibody-conjugated LNP analytical method development and data interpretation
- Collaborate cross-functionally to design bioanalytical strategies for pre-clinical development
- 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, surface ligand density, free antibody, conjugate identity/integrity, and antigen-binding activity
- Author method protocols and analytical development plans aligned with program goals and regulatory requirements
- Ensure GLP and GMP compliance across bioanalytical activities in nonclinical and clinical studies
- Author and review bioanalytical sections of INDs and regulatory submissions
Required qualifications: PhD (6+ years), MS (8+ years), or BS (12+ years) in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field with relevant industry experience. Demonstrated expertise in developing analytical methods for mRNA and LNP products using biophysical and biochemical techniques (particle size measurement, HPLC, LC-MS, CE, ELISA, qPCR, protein analysis, potency assays). Strategic understanding of characterization approaches for mRNA, LNPs, biologics, monoclonal antibodies, and bioconjugations. Hands-on experience with targeted delivery systems and bioconjugation chemistry (maleimide/thiol, click, site-specific conjugation) and their analytics. 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. Cell-based potency assay development experience is highly desirable.
