Senior ADC Analytical Chemistry Lead

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Job summary

Lilly in Indianapolis, IN is seeking a CMC Analytical Chemistry Advisor to lead the analytical development for antibody-drug conjugates, partnering with process chemists and formulation scientists. You will own method development, transfer, and regulatory readiness within BR&D.

We seek a senior scientist with pharma regulatory experience, cross-functional leadership, and strong HPLC/LC-MS/CE expertise to drive quality and robust science in a fast-paced, patient-centered environment.

Qualifications

• Ph.D. in analytical chemistry with 3+ years of pharmaceutical industry experience.
• M.S. in analytical chemistry with 8+ years of pharmaceutical industry experience.
• B.S. in analytical chemistry with 10+ years of pharmaceutical industry experience.
• Proven leadership in CMC analytical development for therapeutic biologics.
• Strong expertise in analytical techniques such as HPLC, CE, LC/MS, impurity profiling/structure elucidation, and method validation.
• Familiarity with ICH guidelines, regulatory requirements and evolving industry trends.

Responsibilities

• Develop and validate analytical methods for ADC conjugated drug substance/drug product; establish control strategy, specifications, impurities and degradation pathways.
• Lead lab activities on purity/impurity method development and analytical testing to support conjugation process development.
• As CMC analytical lead, collaborate within project teams to deliver robust control strategies for ADC drug substances and drug products and mAb intermediates.
• Provide technical oversight for analytical development work internally and by CROs/CMOs; ensure sound method development, characterization, and tech transfer.
• Demonstrate strong technical skills and learning agility across multiple analytical domains (large molecule analytics).
• Support regulatory submissions (IND/BLA) and respond to RtQs; assist pre-approval inspections.
• Mentor and develop scientific staff; manage project timelines and resources.

Skills

HPLC

LC-MS

CE

Impurity profiling

Method validation

Education

Ph.D. in analytical chemistry

M.S. in analytical chemistry

B.S. in analytical chemistry

Job description

Lilly in Indianapolis, IN is seeking a CMC Analytical Chemistry Advisor to lead the analytical development for antibody-drug conjugates, partnering with process chemists and formulation scientists. You will own method development, transfer, and regulatory readiness within BR&D.

We seek a senior scientist with pharma regulatory experience, cross-functional leadership, and strong HPLC/LC-MS/CE expertise to drive quality and robust science in a fast-paced, patient-centered environment.