Principal Scientist, mRNA-tLNP Analytical Development

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.

Location: Boston, MA (hub-based; onsite)

Responsibilities

• Lead the development and execution of bioanalytical methods for early-phase programs
• Serve as a subject matter expert in mRNA, LNP, and antibody-conjugated (targeted) LNP analytical 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

Benefits

• 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.
• Gym membership support.
• 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.