Chemist - GMP Analytical Testing​/Method Lilly Medicine Foundry

Position: Chemist - GMP Analytical Testing / Method Support 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 timely, reliable results that allow Foundry equipment to be released safely and on schedule. In this role, we are seeking a motivated chemist with a strong foundation in HPLC/UPLC and GMP laboratory practices to perform routine testing and support method development, qualification, and validation in a GMP environment. The work supports 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 offers the chance to grow technical skills alongside experienced scientists at a first-of-its-kind facility supporting clinical Phase 1 through Phase 3 supply. You will collaborate with the cleaning validation group, Manufacturing, and Quality, and contribute to building a strong culture of safety, quality, and continuous improvement as the Foundry moves from startup to steady-state operations.

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

+ Perform routine GMP testing of swab and rinse samples using HPLC/UPLC with UV detection to support timely equipment release at the tempo of manufacturing, including sample receipt, preparation, analysis, data review, and reporting.

+ Support development, qualification, and validation of analytical methods for trace-level residues across multiple modalities, including small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds.

+ Execute swab and rinse recovery studies and sample preparation experiments, and evaluate method performance (sensitivity, linearity, accuracy, precision, specificity, and solution stability).

+ Operate, maintain, and troubleshoot HPLC/UPLC instrumentation and chromatographic methods, escalating issues appropriately.

+ Handle samples and standards, including high potency compounds, safely using appropriate containment and HSE practices.

+ Document work accurately and contemporaneously in compliance with cGMP and data integrity (ALCOA+) expectations, and write or assist with analytical procedures, protocols, and reports.

+ Perform data review and participate in investigations of out-of-trend or out-of-specification results and deviations.

+ Collaborate with cleaning validation, Manufacturing, and Quality partners to understand testing needs and prioritize work against the manufacturing schedule.

+ Contribute ideas that reduce cycle times and improve laboratory workflows, and support laboratory readiness activities such as instrument qualification and method transfer.

+ Flex work hours as needed to meet operational demands, including support during shutdowns, weekends, and overnight operations.

** Basic Requirements:*
* + B.S. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related STEM field with 2+ years of relevant laboratory experience; or

+ M.S. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related STEM field with 1+ year of relevant laboratory experience.

+ Hands-on experience with HPLC and/or UPLC with UV detection, including sample preparation, instrument operation, and data processing.

+ Experience working in a GMP laboratory environment, with working knowledge of cGMP, data integrity principles, and good…