Advisor​/Sr. Advisor - Process Chemistry

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- 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.

Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly’s Cell and Gene Therapy (CGT) organization is advancing a growing pipeline of cell and gene therapy products committed to developing groundbreaking therapies for diseases that current approaches cannot address.

We are seeking an exceptional Advisor or Sr. Advisor, to join the lipid process chemistry team. The candidate will support proprietary lipid process chemistry development, characterization, technology transfer, and manufacturing operations for Lilly’s Lipid Nanoparticle Drug Products. The candidate will work as part of a cross functional team to complete late-stage process development activities requiring collaboration across the Lilly network as well as with external contract development laboratories and manufacturing organizations (CDMOs).

This role will provide day-to-day technical support for that work: defining experimental scope, reviewing and interpreting data, troubleshooting process issues, and capturing outcomes in clear, inspection-ready technical documentation. The ideal candidate will have a strong foundation in small molecule and lipid synthesis and purification, experience working with CDMOs, and the ability to translate CDMO-generated data into conclusion-driven reports and regulatory content.

Furthermore, the candidate will possess strong oral and written communication capabilities, demonstrate excellent organization, collaboration, and interpersonal skills, and be adept at problem solving in a fast-paced environment.

• Process chemistry development Provide technical oversight of CDMO process development for proprietary lipids including route scouting, reaction optimization, purification development, and scale-up. Review proposals and track progress against technical objectives, timelines, and deliverables. Provide scientific guidance and troubleshooting to CDMO scientists on day-to-day chemistry challenges.
• Process characterization Apply risk assessment, design of experiments (DoE), and QbD principles to identify critical process parameters, critical quality attributes, and material specifications; support control strategy development. Partner with analytical development on impurity profiling and on the analytical methods supporting lipid characterization. Independently draft conclusion-driven development and characterization reports from protocol objectives and CDMO-generated data Maintain traceable, inspection-ready source documentation supporting regulatory submissions, process knowledge management, and lifecycle documentation requirements.
• Technology transfer Author and review technology transfer packages for transfers between development and cGMP manufacturing, and between CDMOs.
• Manufacturing support Provide…