Lead Deviation Scientist – GMP Analytics

Eli Lilly and Company; Lebanon (IN); On-site; USD 65,250 - 169,400; Full time

Job summary

Eli Lilly and Company is seeking a Principal Scientist for Deviation Management within the Lilly Medicine Foundry in Indiana. This role leads deviation/OOS investigations, crafts CAPA plans, and collaborates with QA, engineering, and manufacturing to ensure right-first-time investigations.

You will mentor junior investigators, champion data integrity, and guide regulatory-ready documentation while supporting cross‑site collaborations in a cutting‑edge facility.

Qualifications

• BS in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, Biology or related field.
• BS with 6+ years or MS with 3+ years GMP manufacturing/QA/lab experience, incl. deviation/OOS investigations.
• Experience authoring investigation protocols, technical reports, and CAPA plans.

Responsibilities

• Lead deviation and OOS investigations (Minor, Major, Critical) with structured root cause analysis.
• Draft and review deviation reports, protocols and CAPA plans.
• Draft CAPA plans and change control records assessing impact to validated processes.
• Perform hands-on troubleshooting and confirmatory testing; partner across QA/SMEs through closure.

Skills

Root cause analysis

Technical writing

Leadership

Mentorship

Quality mindset

Education

BS in Chemistry / Biochemistry / Engineering / Pharmaceutical Sciences

MS in a related GMP field

Tools

TrackWise

Veeva QMS

Job description

Eli Lilly and Company is seeking a Principal Scientist for Deviation Management within the Lilly Medicine Foundry in Indiana. This role leads deviation/OOS investigations, crafts CAPA plans, and collaborates with QA, engineering, and manufacturing to ensure right-first-time investigations.

You will mentor junior investigators, champion data integrity, and guide regulatory-ready documentation while supporting cross‑site collaborations in a cutting‑edge facility.