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

Lilly • Indianapolis, IN

1d • $66,000 - $171,600 • Onsite

About The Position

The Principal Chemist will develop, qualify, validate, and routinely run analytical methods in a GMP laboratory to support cleaning verification and validation at the Lilly Medicine Foundry. The work supports multiple modalities, including small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds, and helps ensure Foundry equipment can be safely released on the manufacturing schedule. Methods will primarily use HPLC/UPLC with UV, CAD, ELSD, and other detection techniques, with LC-MS applied to trace-level residues and compounds with little or no UV chromophore.

This is a hands-on, onsite laboratory role combining analytical method development with routine GMP testing. It offers technical ownership and the opportunity to establish analytical capabilities at a new facility supporting clinical Phase 1 through Phase 3 supply. The chemist will collaborate with Manufacturing, Quality, Process Development, and cleaning validation partners, and provide technical leadership as the Foundry develops from startup to steady-state operations.

Requirements

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

Nice To Haves

• 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, and understanding of residue limit concepts such as health-based exposure limits and MACO.
• Deep fundamental understanding of and hands-on experience with reversed-phase, HILIC, ion-pairing, ion exchange, and/or size-exclusion chromatography, and universal detection techniques such as CAD or ELSD.
• Working knowledge of complementary techniques such as 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 startup.
• Strong hands-on technical skills, learning agility, and ability to prioritize laboratory workload and manage ambiguity.
• Strong communication skills and ability to provide cross-functional leadership while working independently and collaboratively in a dynamic laboratory environment.
• Interest in applying hands-on analytical chemistry to pharmaceutical manufacturing challenges and patient outcomes.

Responsibilities

• Perform hands-on GMP laboratory work to design, develop, and implement analytical methods and testing supporting cleaning validation across multiple modalities.
• Rapidly develop and qualify 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, compounds lacking a UV chromophore, and investigations.
• Perform routine GMP testing of swab and rinse samples, including sample receipt, analysis, data review, and reporting, to support timely equipment release.
• Develop and execute swab and rinse recovery studies and suitable sample preparation approaches; establish method sensitivity, linearity, accuracy, precision, specificity, and solution stability appropriate to residue limits.
• Safely handle and analyze high potency compounds using appropriate containment and HSE practices, and develop methods sensitive enough for low residue limits.
• Write and execute method qualification and validation protocols and reports, author analytical procedures, and support quality investigations, audits, and inspections in compliance with cGMP and ALCOA+ data integrity expectations.
• Collaborate with cleaning validation, Manufacturing, Quality, and Process Development partners to define analytical requirements, understand acceptance limits, and prioritize testing against manufacturing schedules.
• 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 instruments, and lead investigations of out-of-trend or out-of-specification results.
• Introduce platform methods and streamlined workflows to accelerate method development, validation, and routine testing and improve robustness across products.
• Mentor and train junior team members and analysts, encouraging technical growth and knowledge sharing.
• Plan and manage development and testing priorities, coordinate instrument and laboratory capacity, contribute to Foundry laboratory readiness, and communicate progress.
• Adjust work hours as needed to meet operational demands, including support during shutdowns, weekends, and overnight operations.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal