Principal Scientist Biophysical Characterization Full-time

Verve Therapeutics Analytical Development Scientist

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines.

The Analytical Development Group within Verve is comprised of a diverse team of analytical chemists, molecule biologists and pharmaceutical scientists delivering product and process understanding to the LNP-gene therapy systems. Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem solving, and be motivated to work both independently and collaboratively in a dynamic environment.

The Analytical Development group is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages.

Additionally, the role includes testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product, and process characterization. The position is part of a Technical Operations team that partners closely with Quality Control, Quality Assurance, Process Development, and Analytical Research & Development.

Responsibilities

• Develop, optimize, and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
• Collect, process, and analyze experimental data and information applying HPLC, UHPLC, capillary electrophoresis, LCMS, MALS and/or other instrumental analysis techniques, ensure accurate and timely documentation in electronic laboratory notebook.
• Review, interpret, and present data within the analytical team and cross-functional.
• Author, review, and revise technical source documents to support phase-appropriate comparability.
• Provide technical oversight to guide analytical/QC investigations, as needed.
• Actively collaborate with internal and external process development and quality teams.
• Train and mentor junior team members.

Basic Requirements:

• MS in analytical chemistry, biochemistry, or a related field with 7+ years in Biotech or Biopharmaceutical industry
• Minimum of 3 years of experience in LC and CE assay development required

Additional Preferences:

• Strong technical background on analytical methodologies using CE and HPLC for gRNA, mRNA, LNPs
• Hands-on experience developing, qualifying, and troubleshooting biophysical assays using IP-RP, IEX, LC-fluor, multi-modal HPLC/UPLC, capillary electrophoresis (CE), LC-MS, SEC-MALS.
• Experience in method transfer, validation, and implementation to support target candidate validation from non-GxP to GMP environments.
• Experience in advanced characterization instrumentation such as cryo-TEM, NMR, FFF-MALS, DLS, NTA, DSC, AUC, etc.
• Familiarity with applicable ICH regulations related to method validation.
• Proactive, creative, and positive attitude.
• Effective oral and written communication skills.