Advisor​/Senior Advisor, Analytical Chemistry - Antibody-Drug Conjugates

Company Overview

At Lilly, we unite caring with discovery to make life better for people worldwide. The Bioproduct Research and Development (BR&D) organization develops medicines through insulin, peptide, and antibody-drug conjugate programs, providing scientific expertise across discovery, manufacturing, and commercialization.

• Lead analytical development of linker payload intermediates for antibody-drug conjugates, ensuring compliance with regulatory requirements and industry trends.
• Develop, qualify, and validate analytical methods for linker-payload intermediates and related RSMs; establish specifications, impurity profiling, degradation pathways, purge/fate studies, reference standards, and stability studies.
• Collaborate with cross‑functional teams to deliver robust control strategies for linker payload intermediates and process impurities.
• Author IND/CTA, BLA/NDA/MAA, and Response to Questions (RtQ) for global regulatory submissions.
• Provide technical guidance to external networks and ensure methods are technically sound, well developed, and fit‑for‑purpose.
• Execute technology transfer to CRO/CMO and Lilly manufacturing sites.
• Mentor and develop scientific staff, encouraging continuous technical growth and knowledge sharing.
• Introduce new methodologies for antibody‑drug conjugate development and manufacturing optimization.
• Plan and manage short‑term and long‑term development activities, review technical agendas, and allocate resources to achieve project objectives.
• Collaborate with Discovery, Development, and Manufacturing teams to deliver material for clinical trials and regulatory submissions.
• Demonstrate strong communication, organizational, and leadership skills while engaging external stakeholders and incorporating external innovations.

• Ph.D. in chemistry, analytical chemistry, or organic chemistry with 0‑5+ years of pharmaceutical industry experience, or
• M.S. in chemistry, analytical chemistry, or organic chemistry with 6+ years of pharmaceutical industry experience, or
• B.S. in chemistry, analytical chemistry, or organic chemistry with 12+ years of pharmaceutical industry experience.
• Proven experience in CMC analytical development for linker‑payloads/small‑molecule therapeutics or synthetic molecules.
• Strong expertise in HPLC, GC, IC, LC/MS, impurity profiling, structure elucidation, and method qualification/validation.
• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies, authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.

• Strong technical skills to innovate and create business value.
• Experience with analytical method development, control strategy implementation, and/or regulatory submissions related to linker‑payloads or small‑molecule therapeutics.
• Creativity and ability to transform ideas into marketable products and processes.
• Knowledge and experience in managing technical projects.
• Demonstrated leadership capabilities, especially in team environments.
• Ability to drive and accept change, persuade, influence, and negotiate.

0–15% travel required. Potential exposure to chemicals, allergens, and loud noises.

Lilly is a proud EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

The anticipated annual salary for this position ranges from $126,000 to $204,600, depending on education, experience, skills, and geographic location. Eligible full‑time employees also receive a company bonus, 401(k) participation, pension, comprehensive medical, dental, vision, and prescription drug benefits, flexible spending accounts, life insurance, leave of absence benefits, and well‑being programs.