Senior Analytical Lead, ADC Linker–Payload

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

Job summary

Lilly in Indianapolis, IN seeks a senior analytical leader to drive development and regulatory submissions for ADC linker-payload intermediates. You will partner across Discovery, Development, and Manufacturing to ensure robust control strategies and high-quality analytical data for clinical trials and regulatory filings.

The role demands deep expertise in HPLC/LC-MS, method development, and regulatory strategy, with a track record of technical transfer and cross-functional leadership.

Qualifications

• PhD with 3+ years of pharma analytical development experience or MS with 8+ years or BS with 12+ years in pharma.
• Proven leadership in CMC analytical development for linker-payloads or related small molecules.
• Strong expertise in IR, HPLC, GC, LC/MS, KF and impurity profiling and method development.

Responsibilities

• Lead analytical development and commercialization for drug-linker intermediates in ADCs, including method development and validation.
• Author regulatory submissions and respond to health authority questions on analytical topics (IND/CTA, BLA/NDA/MAA).
• Collaborate with project teams to establish robust control strategies for linker-payloads and impurities.
• Drive technical strategies enabling process design for linker-payload intermediates and DS/DP.
• Provide technical oversight for external analytical work; lead tech transfer to CRO/CMO and Lilly sites.
• Mentor team members and introduce new analytical methodologies for ADC development.

Skills

Analytical chemistry expertise

Leadership

Cross-functional collaboration

Analytical method development

Regulatory liaison

Education

PhD in Analytical Chemistry or related field

MS in Analytical Chemistry or related field

BS in Analytical Chemistry or related field

Tools

HPLC

LC/MS

IR

GC

IC

Karl Fischer (KF)

Job description

Lilly in Indianapolis, IN seeks a senior analytical leader to drive development and regulatory submissions for ADC linker-payload intermediates. You will partner across Discovery, Development, and Manufacturing to ensure robust control strategies and high-quality analytical data for clinical trials and regulatory filings.

The role demands deep expertise in HPLC/LC-MS, method development, and regulatory strategy, with a track record of technical transfer and cross-functional leadership.