Advisor / Senior Advisor, Analytical Chemistry - Antibody-Drug Conjugates
Eli Lilly and Company
August 07, 2026
On-site
Indianapolis, IN
Clinical Research and Development
Key Responsibilities
- Develop and validate analytical methods for ADC conjugated drug substance/drug product; establish control strategy and specifications; characterize impurities and degradation pathways; support comparability and stability studies.
- Lead lab activities on purity/impurity method development and analytical testing to support conjugation process development.
- Collaborate as CMC analytical lead to deliver robust control strategies for ADC drug substances and drug products and mAb intermediates.
- Provide technical oversight for analytical development executed internally and by external partners (CROs/CMOs); ensure method development, characterization, and technology transfer.
- Contribute to regulatory submissions (IND authoring, BLA filings), support pre-approval inspections (PAI), and respond to regulatory agency questions (RtQs).
- Mentor and develop scientific staff; support knowledge sharing and technical excellence.
- Plan and manage short- and long-term development activities; define timelines, allocate resources, monitor progress, and adjust as needed.
- Partner with development and manufacturing teams to provide clinical and regulatory deliverables.
- Engage externally to identify and apply advances in analytical chemistry and drug development.
Basic Requirements
- Ph.D. in analytical chemistry with 3+ years in pharma; OR M.S. with 8+ years; OR B.S. with 10+ years.
- Proven leadership in CMC analytical development for therapeutic biologics.
- Expertise in HPLC, CE, LC/MS, impurity profiling/structure elucidation, and method validation.
- Familiarity with ICH guidelines, regulatory requirements, and evolving industry trends.
Additional Preferences
- Method transfer to manufacturing; global regulatory strategy; technical innovation for commercialization; project/team leadership; cross-functional collaboration; communication/organization/leadership; manage ambiguity and competing priorities.
Additional Information
- Travel: 0–10%.
- Location: Onsite, Indianapolis, IN (Lilly Technology Center-North).
Application Instructions
- If you require accommodation for the application process, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Develop and validate analytical methods for ADC conjugated drug substance/drug product; establish control strategy and specifications; characterize impurities and degradation pathways; support comparability and stability studies.
- Lead lab activities on purity/impurity method development and analytical testing to support conjugation process development.
- Collaborate as CMC analytical lead to deliver robust control strategies for ADC drug substances and drug products and mAb intermediates.
- Provide technical oversight for analytical development executed internally and by external partners (CROs/CMOs); ensure method development, characterization, and technology transfer.
- Contribute to regulatory submissions (IND authoring, BLA filings), support pre-approval inspections (PAI), and respond to regulatory agency questions (RtQs).
- Mentor and develop scientific staff; support knowledge sharing and technical excellence.
- Plan and manage short- and long-term development activities; define timelines, allocate resources, monitor progress, and adjust as needed.
- Partner with development and manufacturing teams to provide clinical and regulatory deliverables.
- Engage externally to identify and apply advances in analytical chemistry and drug development.
Basic Requirements
- Ph.D. in analytical chemistry with 3+ years in pharma; OR M.S. with 8+ years; OR B.S. with 10+ years.
- Proven leadership in CMC analytical development for therapeutic biologics.
- Expertise in HPLC, CE, LC/MS, impurity profiling/structure elucidation, and method validation.
- Familiarity with ICH guidelines, regulatory requirements, and evolving industry trends.
Additional Preferences
- Method transfer to manufacturing; global regulatory strategy; technical innovation for commercialization; project/team leadership; cross-functional collaboration; communication/organization/leadership; manage ambiguity and competing priorities.
Additional Information
- Travel: 0–10%.
- Location: Onsite, Indianapolis, IN (Lilly Technology Center-North).
Application Instructions
- If you require accommodation for the application process, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation