Scientist GMP 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.

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 GMP Testing Scientist performs and supports GMP analytical testing for a variety of molecules and modalities at the Lilly Medicine Foundry (LMF), including release testing, in‑process testing, stability testing, and analytical characterization activities. The scientist executes testing in accordance with approved SOPs, analytical methods, and GMP requirements, documenting activities within ELN, LIMS, and associated laboratory systems to ensure data integrity (ALCOA+) and compliant laboratory practices.

The role participates in analytical method transfer, qualification, verification, and lifecycle activities as testing capabilities are insourced from CRO partners and supports cross‑functional analytical readiness and execution for LMF clinical operations. This is a hands‑on, bench‑focused role centered on the execution of GMP analytical testing rather than independent research.

• Execute and support GMP analytical testing for a variety of molecules and modalities—including release, in‑process, stability, and analytical characterization testing—using techniques such as HPLC/UPLC, LC‑MS, GC, UV‑Vis, dissolution, Karl Fisher, FTIR, CE, ELISA, qPCR, and flow cytometry.
• Perform testing in accordance with approved SOPs, analytical methods, and GMP requirements, applying both compendial and non‑compendial methods and platforms.
• Document analytical activities within ELN, LIMS, and associated laboratory systems to ensure data integrity (ALCOA+) and compliant laboratory practices.
• Participate in analytical method transfer, qualification, verification, and lifecycle activities as testing capabilities are insourced from CRO partners.
• Contribute to the authorship of SOPs, protocols, and technical documents, and support laboratory investigations including deviations, out‑of‑specification (OOS), out‑of‑trend (OOT), and atypical results as needed.
• Maintain laboratory readiness by performing reagent and standard preparation, instrument logbook entries, calibration checks, and routine area inspections per 5S/lean lab practices.
• Handle hazardous materials, solvents, and reagents in accordance with EHS requirements and required PPE.
• Collaborate closely with the Sr. Advisor and cross‑functional teams to ensure analytical readiness and execution support for LMF clinical operations.
• Provide leadership in troubleshooting, method lifecycle management, technical mentoring, and scientific decision‑making.

• BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline with
• BS with 3–5 years of GMP testing experience or MS with 1–3 years of GMP testing experience.
• Hands‑on GMP laboratory experience with standard analytical techniques (e.g., HPLC/UPLC, LC‑MS, GC, UV‑Vis, dissolution, FTIR, Karl Fischer, CE, ELISA, qPCR, flow cytometry, or wet chemistry).
• Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role,…