Senior Reference Standards & Stability Scientist

BioSpace; Indianapolis (IN); On-site; USD 129,000 - 246,000; Full time

Benefits offered by this job

Company bonus

401(k) retirement benefits

Health, dental, vision coverage

Paid time off and leave benefits

Job summary

Lilly in Indianapolis, IN seeks a senior Reference Standards Scientist to lead stability studies and manage reference standards across development and regulatory programs, ensuring robust data and compliant documentation.

You will shape technical direction, collaborate with global teams, and mentor scientists while advancing analytical control strategies and ensuring timely support of material deliverables for product testing and regulatory submissions.

Qualifications

• PhD in Chemistry with 3+ years pharma analysis or production experience
• MS in Chemistry with 5+ years pharma analysis or production experience
• BS in Chemistry with 8+ years pharma analysis or production experience
• Expert knowledge of analytical sciences including measurement techniques and statistics

Responsibilities

• Lead reference standard and stability programs across development and regulatory initiatives
• Ensure materials and certifications are scientifically sound and compliant
• Define strategy for source material, packaging, inventory, and protocols
• Partner with global scientists, QA and regulatory leaders for timely support
• Mentor junior staff and lead cross-functional teams on complex projects
• Ensure regulatory commitments and quality systems are maintained

Skills

Analytical chemistry

Leadership

Regulatory knowledge

Statistical analysis

Communication

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

LIMS

Excel

JMP

Job description

Lilly in Indianapolis, IN seeks a senior Reference Standards Scientist to lead stability studies and manage reference standards across development and regulatory programs, ensuring robust data and compliant documentation.

You will shape technical direction, collaborate with global teams, and mentor scientists while advancing analytical control strategies and ensuring timely support of material deliverables for product testing and regulatory submissions.