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

Lilly•Boston, MA

2d•$72,000 - $189,200

About The Position

At Lilly, this role contributes to the discovery and delivery of life-changing medicines. The position designs and executes formulation and process development studies for RNA-lipid nanoparticle (RNA-LNP) drug products and supports technology transfer and manufacture of early-phase clinical trial supplies for assigned projects. The scientist works with multidisciplinary teams on product and process development and platform innovation, collaborating with Discovery, API Development, Analytical Development, Bioproduct Research & Development, CT Operations, and Manufacturing. The role involves developing and scaling RNA-LNP manufacturing processes, characterizing the relationships between process parameters and product quality attributes, and applying analytical methods to assess RNA-LNP products. It also supports transfer of formulations and processes to internal or external manufacturing sites, authors technical documentation, contributes to laboratory and organizational initiatives, and trains and mentors junior colleagues. Work must align with applicable development quality, regulatory, and health, safety, and environmental requirements.

Requirements

Bachelor's degree in chemical engineering, chemistry, pharmaceutical science, biomedical engineering, or a related field with 4 or more years of relevant industry experience, or a master's degree in one of these fields or a related field.
Hands-on experience formulating RNA-LNPs, such as mRNA, siRNA, or other nucleic acid payloads, including preparation by rapid mixing and downstream processing such as TFF, dialysis, and sterile filtration.
Hands-on experience with RNA-LNP analytical methods and interpretation of resulting data.
Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor or support work authorization or visas for this role.
Strong oral and written communication skills.
Proficiency with standard computer and data-analysis tools.

Nice To Haves

Demonstrated initiative and problem-solving ability, including generating ideas, designing experiments to test them, and quickly learning new techniques.
Mechanistic understanding of process engineering principles, including mixing and transport phenomena, unit operations, and scale-down/scale-up, as applied to nanoparticle or parenteral drug products; familiarity with process analytical and characterization tools.
Experience scaling up LNP processes or supporting technology transfer to a clinical manufacturing site or CDMO.
Experience with additional RNA and LNP characterization methods, such as capillary electrophoresis for RNA integrity, nanoparticle tracking analysis, cryo-TEM, or SAXS.
Experience in a pharmaceutical or biopharmaceutical industry setting.
Experience with targeted nanoparticles, process analytical technology, continuous manufacturing, alternative LNP storage presentations, scale-down models, or mathematical modeling.
Track record of innovation, such as publications, patents, conference presentations, or introducing methods or technologies into a laboratory.
Familiarity with regulated environments, including GMP awareness and good documentation practices.
Experience with statistics, design of experiments, scripting, or data visualization.

Responsibilities

Plan, design, and execute experiments with increasing independence; analyze and interpret data and propose next steps.
Manage multiple priorities and collaborate across CMC functions and the discovery-development interface.
Develop and scale LNP manufacturing processes, including rapid-mixing nanoprecipitation, buffer exchange, conjugation, tangential flow filtration, and sterile filtration.
Characterize relationships between process parameters and LNP critical quality attributes using design of experiments and statistical approaches where appropriate.
Perform RNA-LNP characterization using methods such as dynamic light scattering, RiboGreen encapsulation assays, UPLC/HPLC lipid analysis, and RNA integrity methods; interpret results in the context of product quality.
Keep abreast of relevant technologies, evaluate and implement laboratory capabilities, follow scientific literature, and bring new ideas to the team.
Work with senior scientists on platform innovation initiatives, with growing independence.
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 manufacture, including 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, and provide supporting data and technical input to CMC documentation when requested.
Support organizational initiatives such as laboratory operations, equipment ownership, and safety programs.
Interact with external partners, including CDMOs, vendors, and research collaborators, in support of project activities.
Train and mentor junior scientists, associates, and interns.
Ensure work aligns with applicable PR&D Development Quality, regulatory, and HSE requirements, and maintain complete and timely laboratory records.
Approach technical challenges with curiosity and creative problem solving and remain open to trying new methods.
Demonstrate communication skills, follow procedures and instructions, attend to detail, perform sample forecasting, and retrieve and compile data from appropriate databases.

Benefits

Company bonus for full-time equivalent employees, depending in part on company and individual performance.
Eligibility to participate in a company-sponsored 401(k).
Pension.
Vacation benefits.
Eligibility for medical, dental, vision, and prescription drug benefits.
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
Life insurance and death benefits.
Certain time off and leave of absence benefits.
Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
Employee resource groups open to all employees.