Lead Deviation & CAPA Scientist – GMP Analytics

Biopharma Careers; Lebanon (KY); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical coverage

Flexible benefits

Life insurance

Time off

Job summary

Lilly Medicine Foundry in Lebanon, Indiana seeks a Principal Scientist – Deviation Management to lead GMP deviation investigations and CAPA development. You will coordinate with Manufacturing, QA, and Engineering and draft robust change controls to support validated processes.

The role emphasizes data integrity, rigorous root-cause analysis, and mentoring junior staff within the Analytical Compliance Excellence program, ensuring inspection readiness.

Qualifications

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

Responsibilities

• Lead deviation and OOS investigations across Minor, Major, and Critical categories.
• Draft and review CAPA plans and change controls with defensible rationale.
• Mentor junior investigators and support regulatory inspections.

Skills

Root cause analysis

Technical writing

GMP compliance

Data integrity (ALCOA+)

Education

BS in Chemistry/Engineering/Pharmaceutical Sciences

MS in related field (preferred)

Tools

TrackWise

Veeva QMS

Lab informatics

Job description

Lilly Medicine Foundry in Lebanon, Indiana seeks a Principal Scientist – Deviation Management to lead GMP deviation investigations and CAPA development. You will coordinate with Manufacturing, QA, and Engineering and draft robust change controls to support validated processes.

The role emphasizes data integrity, rigorous root-cause analysis, and mentoring junior staff within the Analytical Compliance Excellence program, ensuring inspection readiness.