Advisor, LNP Characterization — Analytical Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Position Summary

Analytical 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

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.