Principal Scientist Deviation Management Lilly Medicine Foundry

Overview

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. Lilly has 50,000+ employees globally and focuses on discovering and delivering life-changing medicines, strengthening health understanding and management, and supporting the communities we serve. 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.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a center for advanced manufacturing and drug development that combines research and manufacturing in a single location to optimize processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact.

Analytical GMP Laboratories (AGL) supports GMP testing across the Lilly Medicine Foundry (LMF) and the broader Product Research & Development (PRD) network, spanning environmental monitoring, microbiology, GMP testing, raw materials, and cleaning/investigations. AGL sits at the intersection of science and quality — this role shapes the analytical compliance program and helps drive quality culture at a cutting-edge facility.

Deviation Investigation Leadership

• Lead deviation and out-of-specification (OOS) investigations (Minor, Major, Critical), applying structured root cause analysis methods (5-Why, fishbone/Ishikawa, fault tree, Is/Is-Not) to determine true root cause.
• Author and review deviation reports, investigation protocols, and CAPA plans with clear, defensible rationale that meets data integrity (ALCOA+) standards and regulatory scrutiny.
• Draft CAPA plans that are risk-appropriate, measurable, and linked to verified root causes, and author change control records assessing impact to validated processes, equipment, and systems.
• Perform hands-on troubleshooting and confirmatory testing to distinguish true deviations from analytical or process anomalies; partner with QA, SMEs, and stakeholders from assignment through closure to keep the deviation portfolio on track for right-first-time, on-time completion, and may lead Deviation Review Board meetings.

Quality System & Compliance Excellence

• Serve as a thought leader on the Analytical Compliance Excellence (ACE) team, championing quality priorities across AGL and supporting audit readiness through clear deviation and CAPA rationale.
• Drive process improvement based on deviation metric analysis, contribute to AGL’s continuous improvement roadmap, and support data integrity and training initiatives.

Trend Analysis & Metrics

• Lead cross-functional analysis of investigation trends and deviation metrics, translating data into actionable insights; track deviation, OOS, CAPA, and change control records to closure, escalating at-risk items to leadership.

Mentorship & Capability Building

• Mentor junior investigators and analytical staff on root cause analysis, technical writing, and quality impact evaluation, serving as a go-to resource for GMP compliance and investigation strategy across AGL.

Cross-Functional Collaboration

• Partner with Manufacturing, Quality Assurance, Analytical/QC, Engineering, and AGL branch leads to scope investigations, verify corrective actions, and confirm CAPA effectiveness — engaging the broader PRD network and external labs for cross-site work as needed.
• Collaborate with the Senior Advisor on investigation strategy, CAPA prioritization, and change control decisions requiring elevated judgment; may participate in deviation governance teams and other quality initiatives.

• BS in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, Biology, or a related scientific/technical discipline.
• BS with 6+ years or MS with 3+ years of progressive GMP manufacturing, quality, or laboratory experience, including direct experience with deviation and OOS investigations, root cause analysis, and CAPA.
• Demonstrated experience authoring investigation protocols, technical reports, and CAPA plans in a regulated environment.
• Qualified applicants must be authorized to work in…