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

Kernal Biologics, Inc.; Boston (MA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Healthcare coverage

Parking or transit

Bluebikes membership

Gym membership

Flexible Spending Account

Paid parental leave

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Bioanalytical method development

mRNA/LNP analytics

Regulatory submissions support

GMP/GLP compliance knowledge

CRO/CDMO oversight

Ausbildung

PhD in Chemistry/Biochemistry/Biology

MS in related field

BS in related field

Jobbeschreibung

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.