Global Lead, Reference Standards & Stability – Bioproduct R&D

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 129,000 - 246,000; Full time

Benefits offered by this job

401(k) matching

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Time off and leave

Well-being programs

Job summary

Eli Lilly and Company is seeking a leader for the Corporate Reference Standards Organization (CRSO) to define and drive technical strategy for reference materials and stability across global labs. You will lead cross-functional teams, oversee data-driven decisions, and ensure regulatory readiness.

The role requires advanced chemistry expertise, strong project management, and a track record of delivering technically complex programs in a regulated environment. Travel up to 15% may be required.

Qualifications

• PhD in Chemistry with 3+ years pharma analysis or production experience; or MS with 5+ years; or BS with 8+ years.
• Expert knowledge of analytical sciences including measurement techniques, specifications, and data analysis.
• Experience with reference standards and stability.
• Proven record of leading complex projects and cross-functional teams.
• Understanding of chemical synthesis, purification, formulation, packaging, and inventory management.
• Ability to set priorities in a changing environment while maintaining accuracy.
• Strong influencing, coaching, and mentoring skills.
• Experience with computerized inventory management and LIMS systems.

Responsibilities

• Apply expert knowledge of reference standards and stability to resolve high-impact technical problems.
• Own and improve reference standard and stability quality systems and processes.
• Set technical strategy for source material selection, packaging design, and inventory management.
• Lead global technical teams to interpret complex data sets and reach data-driven conclusions.
• Define statistical approaches and calculations to support analytical testing decisions.
• Meet global regulatory commitments and contribute to regulatory submissions.
• Monitor regulatory guidance and translate changes into CRSO strategy.
• Lead portfolio of complex projects and deliver on time with minimal oversight.

Skills

Analytical science expertise

Statistical analysis

Project management

Effective communication

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

LIMS systems

Excel

JMP

Job description

Eli Lilly and Company is seeking a leader for the Corporate Reference Standards Organization (CRSO) to define and drive technical strategy for reference materials and stability across global labs. You will lead cross-functional teams, oversee data-driven decisions, and ensure regulatory readiness.

The role requires advanced chemistry expertise, strong project management, and a track record of delivering technically complex programs in a regulated environment. Travel up to 15% may be required.