Principal Chemist – GMP Analytical Method Development and Testing Lilly Medicine Foundry

The analytical team supporting Cleaning Validation delivers the scientific evidence and timely results that allow Foundry equipment to be released safely and on schedule. The role is a hands-on, onsite laboratory role that combines method development with routine GMP testing at the tempo of manufacturing, supporting cleaning verification and validation across small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds, supporting clinical Phase 1 through Phase 3 supply at the Lilly Medicine Foundry.

Responsibilities

Perform hands-on laboratory work in a GMP environment to design, develop, and implement analytical methods and testing supporting cleaning validation across multiple modalities; Rapidly develop and qualify HPLC/UPLC methods with UV, CAD, ELSD, and other detection techniques for cleaning validation and verification of API, intermediate, and cleaning agent residues; Apply LC-MS to develop sensitive, selective methods for trace-level residues, degradants, and compounds lacking a UV chromophore, and support investigations; Perform routine GMP testing of swab and rinse samples to support timely equipment release, including sample receipt, analysis, data review, and reporting; Develop and execute swab and rinse recovery studies and sample preparation approaches, and establish method sensitivity, linearity, accuracy, precision, specificity, and solution stability; Safely handle and analyze high potency compounds using appropriate containment and HSE practices; Write and execute method qualification/validation protocols and reports, author analytical procedures, and support quality investigations, audits, and inspections in compliance with cGMP and ALCOA+ expectations; Collaborate with cleaning validation, Manufacturing, Quality, and Process Development partners to define analytical requirements and prioritize testing; Lead technology transfer of methods to the Foundry quality control laboratory, other Lilly sites, and external partners, and provide technical oversight of external analytical work; Troubleshoot chromatographic and mass spectrometric methods and instrumentation, and lead investigation of out-of-trend or out-of-specification results; Introduce platform methods and streamlined workflows to accelerate method development, validation, and routine testing; Mentor and train junior team members and analysts; Plan and manage development and testing priorities, coordinate instrument and laboratory capacity, contribute to Foundry laboratory readiness, and communicate progress; Flex work hours as needed, including support during shutdowns, weekends, and overnight operations

Requirements

M.S. in Analytical Chemistry, Chemistry, Organic Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related STEM field with 5+ years of relevant experience in the pharmaceutical industry, or B.S. in one of these fields with 8+ years of relevant experience in the pharmaceutical industry; Hands-on experience developing HPLC and/or UPLC methods with UV and other detectors such as CAD or ELSD; Hands-on experience with liquid chromatography-mass spectrometry (LC-MS) for method development or sample analysis; Experience performing routine analytical testing and method development/qualification/validation in a GMP laboratory; Working knowledge of cGMP, data integrity principles, and good documentation practices; Authorized to work in the United States on a full-time basis (Lilly will not sponsor work authorization or visas for this role)

Nice to have

Direct experience with cleaning validation or cleaning verification analytical methods, including swab/rinse recovery studies and trace-level residue analysis; Experience analyzing multiple modalities, including small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds; Experience with high potency compounds, including containment practices and low residue limit methods; Understanding of residue limit concepts (e.g., health-based exposure limits and MACO); Deep fundamental understanding of reversed-phase, HILIC, ion-pairing, ion exchange, and/or size-exclusion chromatography; Working knowledge of TOC, conductivity, UV/Vis, or FTIR; Proficiency with chromatography data systems (e.g., Empower) and electronic laboratory notebooks; Experience with recognized structured, risk-based, or Quality by Design method development approaches; Experience with method transfer, instrument qualification, or laboratory start-up; Strong communication skills and cross-functional leadership ability

Benefits

Company bonus eligibility for full-time equivalent employees (depending on company and individual performance); Company-sponsored 401(k); Pension; Vacation benefits; Medical, dental, vision and prescription drug benefits; Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); Life insurance and death benefits; Certain time off and leave of absence benefits; Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)