Principal Scientist (R3) – CRO Lab Qualification & Onboarding, Bioanalytical Outsourcing

Role: Principal Scientist leading Lilly's bioanalytical outsourcing for small molecules, biologics, and gene therapies, focusing on CRO qualification, onboarding, and oversight. Responsibilities: evaluate and integrate external labs, oversee method development and validation, ensure regulatory compliance, and collaborate cross-functionally with Discovery, Non-Clinical, and Clinical teams. Develop and maintain vendor relationships, provide scientific guidance, and mentor colleagues. Requirements: Bachelor's in a scientific discipline with 7+ years or Master's with 5+ years in regulated bioanalytical labs, with expertise in LC-MS, ligand binding, PCR, or related platforms. Experience with regulated bioanalytical development, validation, and CRO oversight in GxP environments. Preferred: knowledge of ICH M10 BMV, GLP/GCP, and project management skills. High-value: supports Lilly’s pipeline of small molecules, biologics, oligonucleotides, peptides, and gene therapies, across all development stages, with approximately 25% travel. Work setup: US-based, full-time role.