Analytical Lead, TIDES – Early-Phase Peptides & Oligos

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

Job summary

Lilly, headquartered in Indianapolis, IN, is seeking a Senior Research Advisor / Research Advisor in Analytical Chemistry for its SMDD organization. You will lead analytical strategy for early-phase TIDES molecules, coordinating with internal teams and external CMO/CRO partners to enable IND/CTAs and first-in-human programs.

The role requires advanced expertise in chromatography and mass spectrometry, GMP/ICH compliance, and strong cross-functional communication to deliver robust control

Qualifications

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a closely related discipline with 2+ years of industry experience; or MS with 5+ years; or BS with 7+ years.

Responsibilities

• Serve as the analytical lead for early-phase TIDES molecules, owning the phase-appropriate control strategy for drug substance and drug product.
• Provide technical direction to CMO/CRO partners: define deliverables, approve method development and qualification reports, oversee transfers, and drive investigations.
• Oversee GLP and GMP campaigns: readiness, release/testing, reference standard qualification, data reviews, and disposition with Quality.
• Author/review CMC sections of INDs/CTAs—procedures, validation summaries, specifications, impurity and stability sections.
• Establish phase-appropriate specifications and stability programs addressing related substances, impurities, solvents, potency, and microbiological quality.
• Collaborate with chemists, formulation scientists, engineers, Quality, and Regulatory CMC to integrate analytical strategy with program plans.

Skills

Analytical chemistry

Mass spectrometry

Chromatography

Regulatory CMC

Written communication

GMP experience

Cross-functional collaboration

Education

PhD in analytical chemistry or bioanalytical chemistry

MS in analytical chemistry (5+ years)

BS in related field (7+ years)

Tools

LC-MS

HPLC

NMR/UV/GC

Job description

Lilly, headquartered in Indianapolis, IN, is seeking a Senior Research Advisor / Research Advisor in Analytical Chemistry for its SMDD organization. You will lead analytical strategy for early-phase TIDES molecules, coordinating with internal teams and external CMO/CRO partners to enable IND/CTAs and first-in-human programs.

The role requires advanced expertise in chromatography and mass spectrometry, GMP/ICH compliance, and strong cross-functional communication to deliver robust control