Advisor, LNP Process Development and Platform Innovation

Roles and Responsibilities

• Drive the team's RNA-LNP innovation agenda through publications, presentations, and industry influence. Build a platform process toolbox across formulations and scales, using mechanistic understanding and modeling to flag risks early and accelerate development across the Lilly portfolio.
• Develop mechanistic understanding of key RNA-LNP unit operations, including rapid-mixing nanoprecipitation, tangential flow filtration, conjugation, and sterile filtration, and of how process design impacts critical quality attributes such as particle size, polydispersity, encapsulation efficiency, RNA integrity, and lipid content, utilizing state-of-the-art analytical techniques.
• Build process capabilities at lab, early-phase clinical, and scale-up scales, and evaluate and implement new manufacturing and characterization technologies for RNA-LNP drug products.
• Advance RNA-LNP portfolio assets from scale-up through early-phase clinical manufacture: mitigate scale-up risks, support project management and technical leaders in executing complex tech transfers to internal and external manufacturing sites, support GMP readiness, and implement processes to deliver clinical trial material.
• Ensure consistent technical deliverables and documentation across RNA-LNP transfers, including authoring technical reports and drug product CMC sections of early-phase regulatory filings, generating supporting data, and addressing health-authority CMC questions with support from colleagues.
• Work across the discovery-development interface, engaging early with discovery colleagues to identify risks and accelerate the progression of candidates into development.
• Establish and leverage strategic relationships with academic and industry partners, CDMOs, and vendors to accelerate and access emerging innovation in RNA-LNP delivery.
• Mentor and develop junior scientists, associates, and interns, and review protocols, technical reports, and development summaries.
• Ensure work meets Development Quality, regulatory, and HSE requirements, with complete and timely records.

Basic Qualifications

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field.

Additional Skills and Preferences

• Prior experience in nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development.
• Self-driven, highly motivated, and independent fast learner who is eager to try new techniques, stays current with the scientific literature, and thinks creatively to solve problems, while collaborating and communicating effectively across teams.
• Deep mechanistic understanding of unit operations and a solid grasp of engineering fundamentals for designing and optimizing manufacturing processes and drug delivery platforms are highly preferred.
• Experience with development and tech transfer of RNA-LNP formulations is strongly preferred.
• Hands-on experience working with process equipment from lab to pilot scales is preferred.
• Familiarity with routine and advanced analytical techniques used to characterize RNA-LNPs (e.g., DLS, SAXS, cryo-TEM, SEC, HPLC, AF4, RNA integrity and encapsulation assays) is preferred.
• Previous experience with regulatory submissions of RNA-based therapies is preferred.
• Experience with mathematical modeling, whether mechanistic or data-driven, is a plus.
• Experience with laboratory and scientific workflow automation, agentic AI integration, and data infrastructure (e.g., data capture, aggregation, integration, and pipelines connecting instruments, ELN/LIMS, and analytics platforms) is a plus.
• Experience with process analytical technology (PAT) and continuous manufacturing is a plus.
• Proficiency in statistics, design of experiments, data analysis, and reporting.
• Strong publication and presentation record.

Additional information

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 $168,000 - $268,400

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.

#WeAreLilly