Organization Overview:The Delivery, Device and Connected Solutions (DDCS) organization at Eli Lilly designs, develops, and commercializes drug delivery systems, devices, and packaging that bring medicines to patients around the world. This role sits on the Advanced Delivery Systems (ADS) team, Lilly's engine for innovation and development in nonviral delivery. ADS brings together formulation, analytical, process, and platform capabilities across lipid nanoparticle (LNP) systems, particulate formulations, long-acting injectables, and injection physiology. The team owns technology strategy, platform development, scale-up, and technology transfer, supporting a growing portfolio of genetic medicines from early development through commercialization.
Position Overview:We are seeking a highly motivated scientist with experience in chemistry, manufacturing and control (CMC) of genetic medicines to drive innovation efforts in the process engineering and formulation development of genetic medicine programs. Located at the Lilly Institute of Genetic Medicine in Boston, this position seeks a candidate with hands-on experience in process development of nonviral delivery vehicles. This candidate would be responsible for designing and executing formulation and process development studies for RNA-lipid nanoparticle (RNA-LNP) drug products, and for supporting technology transfer and manufacture of early-phase clinical trial supplies for assigned projects. The scientist will work closely with other scientists as part of multidisciplinary teams that provide support for product and process development, interacting with Discovery, API Development, Analytical Development, Bioproduct Research & Development, CT Operations, and Manufacturing. If you are interested in conducting innovative research, you should consider joining our diverse and high-performing team.
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.
- Develop and optimize RNA-LNP formulations, including storage buffer and excipient selection, to meet target product profiles for clinical programs.
- Develop and scale LNP manufacturing processes, including rapid-mixing nanoprecipitation (e.g., microfluidic or impinging-jet mixing), buffer exchange and concentration by 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.
- Conduct formulation and stability studies (e.g., storage temperature, freeze-thaw, in-use) to support selection of clinical formulations and storage conditions.
- 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.
- 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.
- Provide hands-on support for the manufacture of early-phase clinical supplies.
- 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.
- Present data at team meetings and, as appropriate, at deep dive, formulation, or other technical forums.
- Work with Analytical Development to characterize Drug Product physical and chemical stability; coordinate sample submission and analytical testing support.
- Keep abreast of relevant new technologies and capabilities and help evaluate/implement new laboratory capabilities.
- 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.
- Good communication skills, ability to follow procedures and instructions, and attention to detail; perform sample forecasting and retrieve and compile data from appropriate databases.
Basic Requirements:- Earned Bachelor's degree in pharmaceutical science, chemistry, biomedical engineering, chemical engineering, or a related field with 4+ years of experience
- Hands-on experience formulating RNA-LNPs (e.g., mRNA, siRNA, or other nucleic acid payloads), including LNP preparation and downstream processing (e.g., TFF, dialysis, sterile filtration).
- Understanding of stability issues associated with RNA-LNP, as well as familiarity with analytical methods to measure them.
- Familiarity with working in a regulated environment (e.g., GMP awareness, good documentation practices).
- Strong oral and written communication skills are essential, including experience with technical and report writing.
- Ability to interpret and apply scientific and experimental data
- Proficiency with standard computer and data-analysis tools.
- 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.
Additional Preferences:- Earned Master's degree in pharmaceutical science, chemistry, biomedical engineering, chemical engineering, or a related field with 1+ years of relevant experience.
- Hands-on experience with RNA-LNP analytical methods (dynamic light scattering (DLS), RiboGreen encapsulation assays, UPLC/HPLC lipid analysis, and RNA integrity methods, etc.).
- Experience with statistics/design of experiments, scripting, or data visualization is 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, etc.).
- Experience working in a pharmaceutical or biopharmaceutical industry setting.
- Job level placement is ultimately based on depth and scope of relevant experience.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$72,000 - $215,600
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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