Senior Reference Standards & Stability Scientist

Eli Lilly and Company

Indianapolis (IN)

On-site

USD 129,000 - 246,000

Full time

10 days ago

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Benefits offered by this job

401(k) plan
Pension
Vacation benefits
Well-being benefits

Job summary

Lilly in Indianapolis seeks a Reference Standard and Development Stability Scientist to lead stability studies and reference standards programs within CRSO, delivering scientifically sound materials and compliant documentation across global development and testing.

The role requires a PhD/MS/BS in Chemistry with pharma analytics experience, strong leadership, and expertise in analytical methods, statistics, and regulatory affairs. Collaborative, global work is essential.

Qualifications

  • PhD in Chemistry with 3+ years in pharma analysis or MS with 5+ years or BS with 8+ years of pharma analysis experience.
  • Expert knowledge of analytical sciences including measurement techniques and data analysis.
  • Proven experience with reference standards and stability.
  • Strong leadership of cross-functional teams and complex projects.
  • Excellent communication with senior leaders and regulatory audiences.

Responsibilities

  • Apply expert knowledge of reference standard and stability science to resolve high-impact problems.
  • Own and improve the reference standard and stability quality system and processes.
  • Set strategy for source material selection, packaging, inventory, and regulatory compliance.
  • Lead global technical teams to interpret complex data and drive conclusions.
  • Define statistical methods and support analytical testing and regulatory submissions.
  • Coordinate with regulators and ensure timely material deliverables across sites.

Skills

Analytical chemistry
Regulatory knowledge
Statistical analysis
Leadership
Cross-functional collaboration

Education

PhD in Chemistry
MS in Chemistry
BS in Chemistry

Tools

LIMS systems
Excel
JMP

Job description

Lilly in Indianapolis seeks a Reference Standard and Development Stability Scientist to lead stability studies and reference standards programs within CRSO, delivering scientifically sound materials and compliant documentation across global development and testing.

The role requires a PhD/MS/BS in Chemistry with pharma analytics experience, strong leadership, and expertise in analytical methods, statistics, and regulatory affairs. Collaborative, global work is essential.

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