Principal Chemist – GMP Analytical Method Development, Testing

Eli Lilly and Company

. Design, develop, qualify, validate, and implement analytical methods and testing supporting cleaning validation across multiple modalities .

Posted 10/26/2026full-timeLebanon • United StatesLead💰 $66,000 - $171,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing and validating analytical methods for cleaning validation, including HPLC, UPLC, and LC-MS techniques. Proficient in GMP practices, method qualification, and cross-functional collaboration within the pharmaceutical industry.

Highest-signal resume keywords

HPLC Method DevelopmentLC-MS Method DevelopmentGMP Testing ExperienceCleaning Validation ExpertiseChromatography Data Systems Proficiency

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

HPLCUPLCLC-MSAnalytical Method ValidationCleaning ValidationChromatography TechniquesData Integrity PrinciplesMethod QualificationSwab/Rinse Recovery StudiesQuality by Design Approaches

Soft Skills

CommunicationCross-Functional LeadershipLearning AgilityPrioritizationCollaboration

Tools & Technologies

EmpowerElectronic Laboratory NotebooksUV/VisFTIRTOCConductivity

Industry Keywords

Pharmaceutical IndustryCGMPHigh Potency CompoundsHealth-Based Exposure LimitsMACOTrace-Level Residue AnalysisAnalytical TestingMethod TransferLaboratory Start-UpInstrument Qualification

About the role

Key responsibilities & impact

Design, develop, qualify, validate, and implement analytical methods and testing supporting cleaning validation across multiple modalities
Develop HPLC/UPLC methods using UV, CAD, ELSD, and other detection techniques for API, intermediate, and cleaning agent residues
Apply LC-MS to develop sensitive and selective methods for trace-level residues, degradants, and low-chromophore compounds
Perform routine GMP testing of swab and rinse samples, including sample receipt, analysis, data review, and reporting
Develop and execute swab and rinse recovery studies and sample preparation approaches
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 and validation protocols and reports, author analytical procedures, and support investigations, audits, and inspections
Collaborate with Cleaning Validation, Manufacturing, Quality, and Process Development partners
Lead technology transfer to the Foundry quality control laboratory, other Lilly sites, and external partners
Provide technical oversight of external analytical work
Troubleshoot chromatographic and mass spectrometric methods and lead out-of-trend or out-of-specification investigations
Introduce platform methods and streamlined workflows to improve development, validation, testing, and robustness
Mentor and train junior team members and analysts
Plan and manage development and testing priorities, coordinate instrument and laboratory capacity, contribute to laboratory readiness, and communicate progress
Flex work hours as needed to support manufacturing operations, including shutdowns, weekends, and overnight operations

Requirements

What you’ll need

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 the same 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 support or sponsor work authorization or visas
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, containment practices, low residue limit methods, health-based exposure limits, and MACO
Deep understanding and hands-on experience with reversed-phase, HILIC, ion-pairing, ion exchange, and/or size-exclusion chromatography, and CAD or ELSD
Working knowledge of TOC, conductivity, UV/Vis, or FTIR
Proficiency with chromatography data systems such as Empower and electronic laboratory notebooks
Ability to develop methods quickly using structured, risk-based, or Quality by Design approaches and reduce analytical workflow cycle times
Experience with method transfer, instrument qualification, or laboratory start-up
Strong hands-on technical skills, learning agility, prioritization, communication, cross-functional leadership, and ability to work independently and collaboratively
Flexibility to adjust work hours, including shutdowns, weekends, and overnight operations
Potential exposure to chemicals, allergens, high potency compounds, and loud noises

Benefits

Comp & perks

Company bonus depending, in part, on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities