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

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

** Organization and

Position Overview *
* Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The analytical team supporting Cleaning Validation delivers the scientific evidence and timely results that allow Foundry equipment to be released safely and on schedule. In this role, we are seeking an experienced, innovative, and motivated chemist to rapidly develop, validate, and routinely run HPLC/UPLC methods (UV, CAD, ELSD, and other detection, with mass spectrometry for trace-level and low-chromophore residues) in a GMP environment, supporting cleaning verification and validation across multiple modalities: small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds.

This is a hands-on, onsite laboratory role that combines method development with routine GMP testing at the tempo of manufacturing. It offers significant technical ownership and the opportunity to build analytical capabilities from the ground up at a first-of-its-kind facility supporting clinical Phase 1 through Phase 3 supply. You will collaborate with Manufacturing, Quality, and Process Development, and your technical leadership will influence how cleaning validation is executed as the Foundry moves from startup to steady-state operations.

** Responsibilities*
* Top candidates for this position will be expected to:

+ Perform hands-on laboratory work in a GMP environment to design, develop, and implement analytical methods and testing that support the cleaning validation strategy across multiple modalities, including small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds.

+ 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 mass spectrometry (LC-MS) to develop sensitive, selective methods for trace-level residues, degradants, and compounds lacking a UV chromophore, and to support investigations.

+ Perform routine GMP testing of swab and rinse samples to support timely equipment release at the tempo of manufacturing, including sample receipt, analysis, data review, and reporting.

+ Develop and execute swab and rinse recovery studies and sample preparation approaches suited to each modality, and establish method sensitivity (LOD/LOQ), linearity, accuracy, precision, specificity, and solution stability appropriate for residue limits.

+ Safely handle and analyze high potency compounds using appropriate containment and HSE practices, and develop methods sensitive enough to meet low residue limits.

+ Write and execute method qualification/validation protocols and reports, author analytical…