Principal Scientist Deviation Management Lilly Medicine Foundry

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

Lilly Technology Center in Lebanon, IN is seeking a Principal Scientist - Deviation Management to lead deviation and OOS investigations, root cause analysis, CAPA development, and change control for Analytical GMP Laboratories (AGL).

You will author and review investigation reports and CAPA plans, mentor junior staff, collaborate cross-functionally with QA, Manufacturing, and Engineering, and drive CAPA effectiveness and audit readiness.

Qualifications

• Minimum BS in science or engineering with GMP experience.
• MS with 3+ years GMP experience preferred.
• Experience authoring investigation protocols, reports, and CAPA plans.

Responsibilities

• Lead deviation and OOS investigations using structured RCA methods.
• Author and review deviation reports, protocols, and CAPA plans.
• Draft change controls and assess impact on validated processes and systems.
• Mentor junior investigators and collaborate with QA/SMEs to closure.
• Support audit readiness by documenting deviation rationale and CAPA effectiveness.

Skills

Root cause analysis

Technical writing

Troubleshooting

Leadership

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Master's degree in relevant field

Tools

TrackWise

Veeva QMS

Lab informatics systems

Job description

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.