Advisor, LNP Characterization

About the Role

Analytical Development (AD) supports formulation, process development, and product release for next-generation RNA-LNP-based therapies within the Advanced Delivery Systems (ADS) organization. This role focuses on the characterization of lipid nanoparticle formulations. The individual will develop and apply a variety of biophysical techniques to characterize nanoparticle polydispersity, morphology, heterogeneity, and aggregation, driving deep product and process understanding.

Key Responsibilities

• Develop and implement biophysical techniques (e.g., nanoFCM, FFF-MALS, SPARTA, NTA) to characterize LNP morphology, size, and polydispersity at the single-particle level.
• Characterize particle-level structural features, including empty/loaded particle ratios, ligand density and valency, cargo loading heterogeneity, and characteristic blebs, to support formulation and process development.
• Assess particle aggregation, subvisible particle content, and other stability-relevant attributes using single-particle and orthogonal biophysical techniques.
• Design and execute studies to establish structure-function relationships between nanoparticle biophysical attributes and product performance (e.g., potency, stability, in vivo behavior).
• Qualify single-particle characterization methods to ensure accuracy, reliability, and reproducibility for critical testing (e.g., process development, formulation screening, comparability, stability).
• Work closely with Process Development, Formulation, and Bioproduct Research and Development to define critical quality attributes (CQAs) related to particle-level heterogeneity and support process/formulation optimization.
• Analyze and interpret complex, high-dimensional single-particle data sets; present findings to stakeholders and provide clear, actionable recommendations to project teams.
• Track and evaluate emerging single-particle and biophysical characterization technologies and recommend their adoption to address evolving scientific and program needs.
• Identify external collaboration opportunities to deepen product and process understanding.

Requirements & Tech Stack

• PhD in biophysics, chemistry, or a related discipline.
• Hands-on experience with single-particle characterization techniques such as nanoFCM, FFF-MALS, SPARTA, and/or NTA.
• Strong understanding of nanoparticle biophysical properties (e.g., size, morphology, surface characteristics) and their relationship to product performance.

Additional Skills And Preferences

• Experience characterizing lipid nanoparticle (LNP)-based drug products, including empty/loaded particle differentiation, ligand density/valency, and cargo loading heterogeneity.
• Experience with orthogonal biophysical characterization techniques (e.g., DLS, cryo-EM, AF4/FFF, analytical ultracentrifugation).
• Experience with other chemistry assays for mRNA, protein, and lipid characterization.
• Excellent critical thinking, problem-solving, and written and verbal communication skills.
• Proven ability to work collaboratively and deliver in a matrixed, cross-functional environment.
• Willingness to take on additional responsibilities as needed.