Principal Scientist Deviation Management Lilly Medicine Foundry

The Principal Scientist - Deviation Management leads deviation and out-of-specification (OOS) investigations, root cause analysis, CAPA development, and change control for Analytical GMP Laboratories (AGL) at the Lilly Medicine Foundry.

Key Responsibilities

• Lead Minor/Major/Critical deviation and OOS investigations using structured root cause analysis (5-Why, fishbone/Ishikawa, fault tree, Is/Is-Not).
• Author and review deviation reports, investigation protocols, and CAPA plans meeting data integrity (ALCOA+) standards and regulatory expectations.
• Draft risk-appropriate, measurable CAPA plans linked to verified root causes; author change control records assessing impact to validated processes, equipment, and systems.
• Perform hands-on troubleshooting/confirmatory testing; partner with QA/SMEs/stakeholders from assignment through closure; may lead Deviation Review Board meetings.
• Serve as an ACE team thought leader; support audit/inspection readiness via clear deviation and CAPA rationale.
• Drive improvements using deviation metrics; track investigations/CAPAs/change controls to closure and elevate at-risk items.
• Mentor junior investigators/analytical staff on RCA, technical writing, and quality impact evaluation.
• Collaborate cross-functionally (Manufacturing, QA, Analytical/QC, Engineering, AGL leads) to verify corrective actions and confirm CAPA effectiveness.

Basic Qualifications

• BS in a relevant science/technical discipline.
• BS with 6+ years or MS with 3+ years progressive GMP manufacturing/quality/lab experience, including deviation/OOS investigations, RCA, and CAPA.
• Experience authoring investigation protocols, technical reports, and CAPA plans in a regulated environment.
• Authorized to work in the U.S. full-time; Lilly does not sponsor visas.

Preferred/Additional Skills

• Working knowledge of ICH/FDA (21 CFR 210/211) and cGMP/data integrity (ALCOA+) principles.
• Experience with TrackWise/Veeva QMS and lab informatics/GMP documentation.
• Strong technical writing and troubleshooting; experience with change controls, risk/impact assessments (e.g., FMEA), and lot association.
• Leadership/critical thinking; experience supporting regulatory inspections/audits.

Other Information

• Location: Lilly Technology Center (initial) and Lilly Medicine Foundry (permanent), Lebanon, IN.
• Travel: 0-10%.
• Shift: first shift; occasional off-shift/weekend/holiday coverage.
• Physical: work in gowned GMP environment; stand extended periods; handle hazardous materials/solvents with PPE.