Position SummaryAnalytical Development (AD) supports formulation, process development, and product release for Lilly's next-generation RNA-LNP-based therapies within the Advanced Delivery Systems (ADS) organization, partnering closely with Process Development, Formulation, Bioproduct Research and Development, Cell and Gene Therapy, and other functions to ensure product quality and safety throughout the development lifecycle.
We are seeking an Advisor to join the AD team, focused on characterization of lipid nanoparticle formulations. Reporting to the Head of Analytical Development, this individual will develop and apply a variety of biophysical techniques to characterize nanoparticle polydispersity, morphology, heterogeneity, and aggregation, driving deep product and process understanding.
The successful candidate will collaborate closely with cross-functional teams and bring self-motivation, independence, and strong hands-on bench skills to a fast-paced, dynamic environment.
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.
Basic Qualifications- PhD in biophysics, chemistry, or a related discipline with 0-3 years of postdoctoral or industry experience characterizing nanoparticle formulations.
- 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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$141,000 - $206,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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