Senior Advisor, E&L Strategy & Impurity Control

Eli Lilly and Company; Indianapolis (IN); On-site; USD 129,000 - 211,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Job summary

Lilly in Indianapolis, IN seeks a scientific leader to set the extractables and leachables (E&L) and elemental impurities strategy across modalities, partnering with BR&D Analytical and external partners to ensure safety and quality from development through commercialization.

The role offers the opportunity to shape regulatory strategies, drive advanced analytics, and lead digital tools integration, including AI-enabled workflows, with travel up to 10%.

Qualifications

• Ph.D. in analytical chemistry, pharmaceutical sciences, or a related field with 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15+ years (or M.S. in chemistry with 10+ years) of experience in the pharmaceutical industry.
• In-depth experience in E&L strategy, study design, and safety/toxicological risk assessment for late-stage and commercial pharmaceutical or biologic products.
• Experience with elemental impurity risk assessment and control strategies, including ICP-MS for elemental analysis.
• Experience leading E&L laboratories, external partner relationships, and/or technical projects at a pharmaceutical company, CDMO, or contract laboratory.

Responsibilities

• Provide strategic leadership for E&L and elemental impurities across modalities and manufacturing systems, collaborating with internal SMEs to establish robust strategies.
• Coordinate end-to-end E&L and elemental impurity strategies, including risk assessment and regulatory-aligned control strategies.
• Provide scientific oversight of externally executed testing, including study design, data interpretation, and reporting.
• Lead regulatory and lifecycle strategies for E&L and elemental impurities, including submissions and regulatory commitments.
• Advance integration of digital tools and AI into E&L workflows to improve efficiency and decision-making.

Skills

Strategic leadership

Regulatory strategy

Cross-functional collaboration

Analytical mindset

Communication skills

Education

Ph.D. in analytical chemistry, pharmaceutical sciences

B.S. in chemistry with 15+ years experience

Tools

ICP-MS

Job description

Lilly in Indianapolis, IN seeks a scientific leader to set the extractables and leachables (E&L) and elemental impurities strategy across modalities, partnering with BR&D Analytical and external partners to ensure safety and quality from development through commercialization.

The role offers the opportunity to shape regulatory strategies, drive advanced analytics, and lead digital tools integration, including AI-enabled workflows, with travel up to 10%.