Principal Scientist Biophysical Characterization

About the role

The Analytical Development group within Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, 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.

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.

Requirements

• MS in analytical chemistry, biochemistry, biophysics or a related field with 4+ years of experience in Biotech or Biopharmaceutical industry
• OR BS in analytical chemistry, biochemistry, biophysics or a related field with 6+ years of experience in Biotech or Biopharmaceutical industry
• Minimum of 3 years of experience in LC and CE assay development required
• Hands-on experience developing, qualifying and troubleshooting biophysical assays using HPLC/UPLC, LCMS and capillary electrophoresis (CE).

Qualifications

• Strong technical background on analytical methodologies using CE and HPLC for gRNA, mRNA, LNPs.
• Experience in method transfer, validation, and implementation to support target candidate validation from non-GxP to GMP environments.
• Familiarity with applicable ICH regulations related to method validation.
• Proactive, creative, and positive attitude.
• Effective oral and written communication skills.