Principal Scientist Deviation Management Lilly Medicine Foundry

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.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first‑ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing 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 offers the opportunity to shape the analytical compliance program from the ground up and help drive quality culture at a cutting‑edge facility.

The Principal Scientist – Deviation Management leads deviation and out‑of‑specification (OOS) investigations, root cause analysis, CAPA development, and change control for AGL at the Lilly Medicine Foundry. Reporting to the Senior Advisor and partnering with Manufacturing, Quality Assurance, and Engineering, this role authors clear, defensible investigation reports and CAPA plans, performs hands‑on troubleshooting to support investigation conclusions, serves as a quality champion on the Analytical Compliance Excellence (ACE) team, and mentors junior investigators.

• 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 holds up to 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.

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

• 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.

• 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.

• Partner with Manufacturing, Quality Assurance, Analytical/QC, Engineering, and AGL branch leads to…