Director, Analytical Chemistry Extended Characterization

Organization & Position Overview

Verve Therapeutics is a wholly owned subsidiary of Lilly. Verve is a biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world‑leading experts in cardiovascular medicine, human genetics and gene‑editing, the company aims to develop transformative, once‑and‑done therapies for coronary heart disease. Verve’s gene‑editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels.

• Lead a team of scientists working on mRNA, gRNA and LNP assays focused on biophysical extended characterization.
• Partner across the Analytical Development team and cross‑functionally with  &D and SMDD to lead, plan, and execute complex characterization studies; serve as the analytical lead in cross‑functional interactions.
• Develop and implement methods intended for product characterization to support late stage and commercialization of gene‑editing programs.
• Provide technical expertise for the structural characterization of gRNAs, mRNAs and lipid nanoparticle (LNP) complexes.
• Serve as analytical lead for CMC project teams.
• Oversee troubleshooting, tech transfer, and phase‑appropriate GMP validation of analytical methods at the internal Quality Control lab and at contract testing labs in collaboration with Quality team.
• Author and review technical reports and regulatory submissions.
• Provide guidance and support to team members, promoting their professional growth and development.
• Effectively manage multiple projects to ensure timely delivery.
• Foster a culture of lab safety, data integrity, collaboration, innovation, continuous improvement and accountability within the team.
• Other duties as assigned.

• PhD in analytical chemistry or bioanalytical chemistry, or a related field with 10+ years of experience in the pharmaceutical industry.
• Prior laboratory operations and management experience leading a team of scientists and associates for analytical development in a clinical stage biotech environment.
• Prior experience must include performing analytical assays to support the development of lead molecules, troubleshooting and optimizing analytical assays for GMP use per ICH guidelines.
• Experience with planning and executing product and process development studies such as forced degradation, comparability assessments, stability, extended characterization, etc.
• Experience with analytical control strategy implementation, and/or regulatory submissions related to advanced gene therapies.
• Direct experience analyzing LNPs and RNA by biophysical techniques such as LC‑MS, DSC, DLS, MALS, etc.
• Demonstrated competency in operating HPLC/UPLC/LC‑MS instrumentation.
• Hands‑on experience analyzing DNA/RNA by IP‑RP, IEX, LC‑fluor and multi‑modal LC techniques required.
• Conceptual understanding of solid phase oligonucleotide synthesis and purification strategies.
• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.
• Demonstrated success in persuasion, influence, and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and manage ambiguity.
• Ability to influence others to promote a positive work environment.
• Demonstrated technical proficiency and ability to create ideas for future work plans.

• Knowledge/hands‑on experience in oligonucleotide lipid nanoparticle delivery, production and purification of short and large oligonucleotides, protein engineering and process development are a plus, but not required.

• Travel: 15‑30% (initial 4‑6 months travel to Verve Boston site required)
• Potential exposure to chemicals, allergens, and loud noises.
• Position location:
  
  Indianapolis, IN;
  Lilly Technology Center‑North (LTC‑N)

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