Senior Research Advisor, Analytical Chemistry (Early-Phase)

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Job summary

Lilly, based in Indianapolis, IN, seeks an analytical lead for early‑phase TIDES programs. You will own the analytical package from preclinical through IND, partnering with CMOs/CMCs and Quality to enable GLP/GMP campaigns and regulatory documentation.

The role requires advanced degree in analytical chemistry with strong MS/LC‑MS expertise, experience in GMP environment, and cross‑functional collaboration to drive robust control strategies and regulatory submissions.

Qualifications

• Ph.D. in analytical or bioanalytical chemistry (2+ years industry) or MS (5+ years) or BS (7+ years).
• Experience in analytical method development, qualification/validation, and transfer for peptides, oligonucleotides, or small molecules.
• Strong MS and chromatography knowledge; familiarity with ICH/USP/Ph. Eur. requirements.
• GMP environment experience and clear cross‑functional communication.

Responsibilities

• Serve as analytical lead for early‑phase TIDES molecules, owning the phase‑appropriate control strategy for drug substance and drug product.
• Provide direction to CMO/CRO partners: define deliverables, approve methods, oversee transfers, and resolve OOS/OOT results.
• Oversee GLP and GMP campaigns, including readiness, testing, reference standard qualification, and batch data review.
• Author/review CMC sections of INDs/CTAs — procedures, validation, specs, impurities and stability; support health authority responses.

Skills

Analytical method development

Method validation

Method transfer

Chromatography

Mass spectrometry

ICH/Ph. Eur./USP knowledge

Communication skills

Education

Ph.D. in analytical or bioanalytical chemistry

M.S. in analytical chemistry

B.S. in a related field

Tools

LC-MS

Job description

Lilly, based in Indianapolis, IN, seeks an analytical lead for early‑phase TIDES programs. You will own the analytical package from preclinical through IND, partnering with CMOs/CMCs and Quality to enable GLP/GMP campaigns and regulatory documentation.

The role requires advanced degree in analytical chemistry with strong MS/LC‑MS expertise, experience in GMP environment, and cross‑functional collaboration to drive robust control strategies and regulatory submissions.