Senior E&L and Impurity Strategy Leader - External Partners

BioSpace; Indianapolis (IN); On-site; USD 129,000 - 211,000; Full time

Job summary

Lilly in Indianapolis, IN seeks an experienced scientific leader to set the extractables and leachables (E&L) and elemental impurities strategy across all modalities, serving as the liaison between BR&D Analytical and external CDMO partners. This role shapes safety and quality decisions from development through commercialization and engages with global regulators and industry bodies.

The position emphasizes leadership across modalities, regulatory submissions, and lifecycle strategies, with a

Qualifications

• Ph.D. in analytical chemistry, pharmaceutical sciences, or related field with 5+ years of pharma industry experience.
• 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.
• 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 and data interpretation.
• Partner with global manufacturing sites to enable implementation of E&L strategies for readiness and lifecycle activities.
• Lead regulatory and lifecycle strategies for E&L and elemental impurities, including submissions and health authority responses.
• Provide strategic leadership for container closure systems and best practices, including analytical control strategy and compatibility.
• Advance integration of digital tools and AI into E&L workflows to improve efficiency and decision-making.

Skills

E&L strategy

Regulatory strategy

External partner management

Cross-functional leadership

Data interpretation

Digital tools & AI

Education

Ph.D. in analytical chemistry or related field

5+ years pharma industry experience

Tools

ICP-MS

Job description

Lilly in Indianapolis, IN seeks an experienced scientific leader to set the extractables and leachables (E&L) and elemental impurities strategy across all modalities, serving as the liaison between BR&D Analytical and external CDMO partners. This role shapes safety and quality decisions from development through commercialization and engages with global regulators and industry bodies.

The position emphasizes leadership across modalities, regulatory submissions, and lifecycle strategies, with a