Principal Scientist, Analytical Sciences Full-time

Principal Scientist, Analytical Sciences

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.

Orna Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. With our pioneering circular RNA technology, developed at MIT, we are at the forefront of advancing the next generation of RNA therapeutics. Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.

We are seeking an exceptional Principal Scientist, Analytical Sciences, to join our Analytical Sciences team to run analytical methods for the characterization of RNA therapeutics. The ideal candidate is a motivated individual that can execute chromatography experiments with efficiency and creativity. They should have relevant analytical development experience, possess strong oral and written communication capabilities, demonstrate excellent collaboration & interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities:

• Implement Orna's analytical testing strategy for circular RNA and lipid nanoparticle formulations with a focus on chromatography methods.
• Develop and qualify drug substance and drug product analytical methods and perform characterization studies.
• Build and develop internal analytical capabilities to support in-process, release, stability, and characterization testing of drug products.
• Perform regular maintenance on HPLCs and other laboratory instrumentation.
• Maintain a clean and safe laboratory environment.
• Support method transfers to Contract Research Organizations and provide technical guidance/troubleshooting.
• Review method procedures, method validation protocols, and reports.
• Generate, interpret, and present data to cross-functional R&D teams.
• Contribute to a positive and exciting work environment and a strong entrepreneurial and creative culture.

Basic Requirements:

• BS degree in analytical chemistry, biochemistry, or a similar area, with 6-9 years of relevant experience in analytical method development
• Or MS degree in analytical chemistry, biochemistry, or a similar area with 3+ years of relevant experience in analytical method development
• Experience with HPLC/UPLC and related software is required.
• Experience with development, qualification, validation, and transfer of analytical methods in a GxP environment to support process development, product characterization, release, stability studies, and other analytical studies.

Additional Preferences:

• IP-RP, SEC, and AEX are particularly valued. Knowledge of additional analytical methodologies such as LC-MS, DLS, CE, and/or Spectrophotometry and regulatory requirements is a plus.
• Experience with LNPs and/or mRNA is highly desirable.
• Strong oral and written skills and the ability to work independently with minimal support.

Physical Demands/Travel:

The physical demands of this job are consistent with lab environment.

Work Environment:

This position's work environment is in a laboratory environment.