Senior ADC Linker Payload Analytics Lead

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

Job summary

Lilly in Indianapolis, IN, is seeking a Senior Advisor of Analytical Chemistry for Antibody-Drug Conjugates Linker Payload Development to lead analytical development efforts for ADC programs and to enable clinical trials and regulatory submissions. The role requires a Ph.D. with 3+ years or an M.S.

with 8+ years or a B.S. with 12+ years in pharmaceutical science, with strong skills in LC-MS, HPLC, impurity profiling, and method validation, plus cross‑functional leadership and a drive for

Qualifications

• Ph.D. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 3+ years in pharmaceutical industry.
• M.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 8+ years in pharmaceutical industry.
• B.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 12+ years in pharmaceutical industry.
• Proven leadership in CMC analytical development for linker‑payloads/small molecule therapeutics or synthetic molecules.
• Strong expertise in analytical techniques such as IR, HPLC, GC, IC, LC/MS, KF, impurity profiling/structure elucidation, and method development, qualification/validation.
• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.

Responsibilities

• Lead analytical development and commercialization for the drug-linker intermediate used in ADCs, including method development, qualification/validation, specification-setting, impurity/degradation characterization, reference standard management, and stability studies.
• Author technical reports and 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-payload intermediates and process impurities.
• Drive technical and analytical strategies enabling linker-payload intermediate and conjugated DS/DP process design.
• Provide technical oversight for external analytical work; lead technology transfer to CRO/CMO partners and internal Lilly sites.
• Mentor and develop team members, fostering technical growth and knowledge sharing.
• Introduce new analytical methodologies to advance ADC development and manufacturing.
• Plan and manage development timelines and resourcing; communicate progress and adjust plans.
• Partner across Discovery, Development, and Manufacturing to deliver materials and data for clinical trials and regulatory filings.

Skills

IR spectroscopy

HPLC

GC

IC

LC-MS

KF

Impurity profiling

Structure elucidation

Method development

Method qualification

Validation

CMC leadership

Regulatory submissions

Tech transfer

Education

Ph.D. in Analytical/Organic Chemistry or related field

M.S. in Analytical/Organic Chemistry or related field

B.S. in Analytical/Organic Chemistry or related field

Job description

Lilly in Indianapolis, IN, is seeking a Senior Advisor of Analytical Chemistry for Antibody-Drug Conjugates Linker Payload Development to lead analytical development efforts for ADC programs and to enable clinical trials and regulatory submissions. The role requires a Ph.D. with 3+ years or an M.S.

with 8+ years or a B.S. with 12+ years in pharmaceutical science, with strong skills in LC-MS, HPLC, impurity profiling, and method validation, plus cross‑functional leadership and a drive for