Senior Scientist, mRNA-tLNP Analytics & Bioconjugates

Kernal Biologics, Inc.; Boston (MA); On-site; USD 170,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Healthcare coverage (PPO/HMO)

Free parking

Transit passes

Life insurance

On-site cafeteria

Generous vacation/sick leave

Flexible spending account

Bluebikes membership

Job summary

Kernal Biologics, Inc. is seeking a Principal Scientist for Analytical Development to lead bioanalytical method design and execution for in vivo CAR-T programs.

You will focus on biophysical characterization and in vitro assays for antibody-targeted LNPs, developing robust, regulation-ready analytics. The role requires leadership in GLP/GMP environments, collaboration across teams, and preparation of IND sections to support early clinical programs.

Qualifications

• Expertise in developing analytical methods for mRNA and LNP products (biophysical and biochemical).
• Experience supporting regulatory submissions and ICH-compliant stability programs.
• Experience overseeing CRO/CDMO analytical activities and GMP testing.
• Strong knowledge of CMC regulatory expectations for global submissions.

Responsibilities

• Lead development and execution of bioanalytical methods for early-phase programs.
• Serve as SME in mRNA, LNP, and antibody-conjugated LNP analytical method development.
• Collaborate cross-functionally to design analytics for pre-clinical programs.
• Oversee outsourced bioanalytical studies for mRNA and LNP platforms.
• Develop and qualify methods to characterize antibody–lipid bioconjugates and targeting ligands.
• Author method protocols and development plans aligned with regulatory requirements.

Skills

Bioanalytical method development

mRNA and LNP analytics

GMP/GLP oversight

Regulatory submissions (IND)

Cross-functional collaboration

Strategic scientific leadership

Cell-based potency assays

Education

PhD

MS

BS

Tools

SEC/HPLC

LC-MS

Capillary electrophoresis

ELISA

qPCR

Protein analysis

Job description

Kernal Biologics, Inc. is seeking a Principal Scientist for Analytical Development to lead bioanalytical method design and execution for in vivo CAR-T programs.

You will focus on biophysical characterization and in vitro assays for antibody-targeted LNPs, developing robust, regulation-ready analytics. The role requires leadership in GLP/GMP environments, collaboration across teams, and preparation of IND sections to support early clinical programs.