Principal Scientist; R3 CRO Lab Qualification & Onboarding, Bioanalytical Outsourcing

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. 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 35,000 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.

As a Principal Scientist on our Bioanalytical Outsourcing team, you will take the lead in qualifying and onboarding new Contract Research Organization (CRO) laboratories, building the external network that powers Lilly's growing portfolio of small molecule, oligonucleotide, peptide, biologic, and gene therapy programs, and providing ongoing scientific oversight of CRO performance, data quality, and regulatory compliance after onboarding. This is a high-visibility role at the center of Lilly's expanding bioanalytical capabilities - you will shape how we select, evaluate, and integrate external partners, directly influencing the speed and quality of the data that advances medicines from discovery through the clinic.

You will bring deep bioanalytical expertise and sound scientific judgment to a fast-paced, interdisciplinary team, mentoring colleagues and partnering across Discovery, Non-Clinical, Clinical, Procurement, Quality, and Operations. If you are energized by solving novel technical challenges, building lasting partnerships, and growing your career at the leading edge of bioanalytical science, we want to hear from you! The bioanalytical outsourcing team supports all modalities including small molecules, oligonucleotides, peptides, biologics, and gene therapies across analytical platforms (e.g., ligand binding, LC-MS, PCR).

Together, we ensure the delivery of the bioanalytical data needed to advance Lilly's growing portfolio - offering broad exposure across modalities and platforms as our pipeline continues to expand.

• Lead the qualification and onboarding of new CRO partners for ADME and bioanalytical (bioA) assays, serving as the primary scientific point of contact from initial technical assessment through successful integration.
• Provide independent scientific oversight and strategic guidance to CRO partners for non-regulated and regulated bioanalytical method development, validation, and sample analysis.
• Collaborate and influence cross-functionally with Discovery, Non-Clinical, and Clinical teams to align CRO capabilities with evolving program needs.
• Partner with Procurement, Quality, and Operations to establish and continuously improve CRO qualification standards and processes.
• Build and sustain strategic relationships with internal customers and external vendors, providing bioanalytical method support, troubleshooting, and critical reagent management.
• Mentor scientists and share technical expertise across the bioanalytical outsourcing network.

• Bachelor's degree in a scientific field (e.g., chemistry, biology, or pharmaceutical sciences) with a minimum of 7 years of relevant bioanalytical laboratory experience, OR a Master's degree with a minimum of 5 years Experience in a regulated bioanalytical laboratory setting, including method development, validation, and/or sample analysis.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Understanding of the current ICH M10 BMV guidance requirements and GLP/GCP regulations.
• Prior experience…