Principal Scientist, mRNA-tLNP Analytics for In Vivo CAR-T

Kernal Biologics, Inc.; Boston (MA); Presencial; USD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan

Healthcare coverage

Parking or transit

Bluebikes membership

Gym membership

Flexible Spending Account

Paid parental leave

Descripción de la vacante

Kernal Biologics, Inc. is seeking a Principal Scientist, Analytical Development for its Boston hub. You will lead design, development, and execution of analytical methods to support the mRNA platform and in vivo CAR-T programs, with emphasis on biophysical characterization and antibody-targeted LNPs.

Ideal candidates bring deep expertise in analytical sciences, regulatory submissions, and fit-for-purpose method development and validation aligned with phase-appropriate requirements.

Formación

• PhD/MS/BS with relevant industry experience stated.
• Expertise in developing analytical methods for mRNA and LNP products, including biophysical and biochemical techniques.
• Strong knowledge of regulatory expectations for global submissions (CMC).
• Experience overseeing CRO/CDMO analytical activities and GMP testing.

Responsabilidades

• Lead the development and execution of bioanalytical methods for early-phase programs.
• Serve as SME 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 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 regulatory standards.
• Provide leadership to ensure GLP and GMP compliance in nonclinical and clinical studies.
• Prepare and review bioanalytical sections of INDs and regulatory submissions.

Conocimientos

Bioanalytical method development

mRNA/LNP analytics

Regulatory submissions support

GMP/GLP compliance knowledge

CRO/CDMO oversight

Educación

PhD in Chemistry/Biochemistry/Biology

MS in related field

BS in related field

Descripción del empleo

Kernal Biologics, Inc. is seeking a Principal Scientist, Analytical Development for its Boston hub. You will lead design, development, and execution of analytical methods to support the mRNA platform and in vivo CAR-T programs, with emphasis on biophysical characterization and antibody-targeted LNPs.

Ideal candidates bring deep expertise in analytical sciences, regulatory submissions, and fit-for-purpose method development and validation aligned with phase-appropriate requirements.