Principal Scientist, mRNA-tLNP Analytics & Bioconjugates

Kernal Biologics; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Healthcare coverage

Subsidized commuter options

Gym membership support

On-site cafeteria

Paid parental leave

Job summary

Kernal Biologics, Inc. in Boston, MA is seeking a Principal Scientist, Analytical Development to lead the design, development, and execution of analytical methods for its in vivo mRNA platform.

The role emphasizes biophysical characterization and in vitro assay development for early programs, including antibody-targeted LNPs. The ideal candidate brings deep expertise in analytical sciences, regulatory submissions, and fit-for-purpose method validation to support GLP/GMP compliance and IND

Qualifications

• PhD/MS/BS with significant industry experience in analytical development for mRNA/LNP platforms.
• Experience with biophysical and biochemical techniques including particle sizing, HPLC, LC-MS, CE, ELISA, qPCR, and potency assays.
• Strategic understanding of characterization for mRNA, LNPs, biologics, and bioconjugations.
• Hands-on with targeted delivery systems and bioconjugation chemistry and analytics.
• Oversight of CRO/CDMO analytics and ICH-compliant stability programs and GMP testing.
• Cell-based potency assay development, qualification, and troubleshooting are highly desirable.
• 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 analytics and data interpretation.
• Collaborate cross-functionally to design analytical 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.
• Author method protocols and analytical development plans aligned with program goals and compliance.
• Provide leadership to ensure GLP and GMP compliance across bioanalytical activities in nonclinical and clinical studies.
• Author and review bioanalytical sections of INDs and regulatory submissions.

Skills

Bioanalytical methods

mRNA & LNP analytics

Regulatory submissions

GLP/GMP compliance

CRO/CDMO oversight

Cell-based potency assays

Education

PhD

MS

BS

Tools

HPLC

LC-MS

CE

ELISA

qPCR

SEC/HPLC

Capillary electrophoresis

Job description

Kernal Biologics, Inc. in Boston, MA is seeking a Principal Scientist, Analytical Development to lead the design, development, and execution of analytical methods for its in vivo mRNA platform.

The role emphasizes biophysical characterization and in vitro assay development for early programs, including antibody-targeted LNPs. The ideal candidate brings deep expertise in analytical sciences, regulatory submissions, and fit-for-purpose method validation to support GLP/GMP compliance and IND