Senior Scientist/Principal Scientist, RNA-LNP Formulation and Process Development

Key Responsibilities

• Plan, design, and execute experiments with increasing independence; analyze and interpret data and propose next steps.
• Manage multiple priorities and collaborate effectively across CMC functions and across the discovery-development interface.
• Develop and scale LNP manufacturing processes, including rapid-mixing nanoprecipitation (e.g., microfluidic or impinging-jet mixing), buffer exchange, conjugation, tangential flow filtration (TFF), and sterile filtration.
• Characterize relationships between process parameters and LNP critical quality attributes (e.g., particle size, polydispersity, encapsulation efficiency, RNA integrity, lipid content), using design of experiments and statistical approaches where appropriate.
• Perform RNA-LNP characterization using methods such as dynamic light scattering (DLS), RiboGreen encapsulation assays, UPLC/HPLC lipid analysis, and RNA integrity methods (gel electrophoresis); interpret results in the context of product quality.
• Keep abreast of relevant new technologies and help evaluate/implement new laboratory capabilities.
• Actively follow the scientific literature and bring forward new ideas and approaches to the team.
• Work closely with senior scientists, with growing independence, on platform innovation initiatives.
• Present data at team meetings, internal technical forums, and external conferences as needed.
• Support technology transfer of RNA-LNP formulations and manufacturing processes to internal or external (CDMO) sites for early-phase clinical trial (CT) manufacture, including preparation of transfer documentation and on-site support as needed.
• Recognize technical issues and escalate them to the project lead or management in a timely manner.
• Author technical reports, protocols, and development summaries; provide supporting data and technical input to CMC documentation when requested.
• Support organizational initiatives as required (e.g., laboratory operations, equipment ownership, safety programs).
• Interact with external partners (e.g., CDMOs, vendors, research collaborators) in support of project activities.
• Train and mentor junior scientists, associates, and interns.
• Ensure work is aligned with all relevant PR&D Development Quality, regulatory, and HSE requirements; maintain complete and timely laboratory records.
• Approach technical challenges with curiosity and creative problem solving and be open to trying new methods rather than relying solely on established procedures.
• Demonstrate good communication skills, the ability to follow procedures and instructions, and attention to detail; perform sample forecasting and retrieve and compile data from appropriate databases.

Educational Requirements

• Bachelor's degree in chemical engineering, chemistry, pharmaceutical science, biomedical engineering, or a related field with 4+ of relevant industry experience; OR Master's degree in chemical engineering, chemistry, pharmaceutical science, biomedical engineering, or a related field
• Hands-on experience formulating RNA-LNPs (e.g., mRNA, siRNA, or other nucleic acid payloads), including LNP preparation by rapid mixing and downstream processing (e.g., TFF, dialysis, sterile filtration).
• Hands-on experience with RNA-LNP analytical methods and with interpreting the resulting data.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Preferences

• Demonstrated initiative and problem-solving ability, with evidence of generating new ideas, designing experiments to test them, and quickly learning new techniques.
• Mechanistic understanding of process engineering principles (e.g., mixing and transport phenomena, unit operations, scale-down/scale-up) as applied to nanoparticle or parenteral drug products and familiarity with process analytical and characterization tools are highly desirable.
• Experience scaling up LNP processes or supporting technology transfer to a clinical manufacturing site or CDMO.
• Experience with additional RNA and LNP characterization methods (e.g., capillary electrophoresis for RNA integrity, nanoparticle tracking analysis, cryo-TEM, SAXS).
• Experience working in a pharmaceutical or biopharmaceutical industry setting.
• Experience in any of the following: targeted nanoparticles, process analytical technology (PAT), continuous manufacturing, alternative storage presentations for LNPs, scale-down models, mathematical modeling.
• Track record of innovation (e.g., publications, patents, conference presentations, or introducing new methods or technologies into a laboratory).
• Familiarity with working in a regulated environment (e.g., GMP awareness, good documentation practices).
• Strong oral and written communication skills are essential.
• Proficiency with standard computer and data-analysis tools.
• Experience with statistics/design of experiments, scripting, or data visualization is desirable.