Scientist GMP Testing Lilly Medicine Foundry

Responsibilities

• Execute and support GMP analytical sing for a variety of molecules and modalities — including release, in-process, stability, and analytical characterization sing — using techniques such as HPLC/UPLC, LC-MS, GC, UV-Vis, dissolution, Karl Fischer, FTIR, CE, ELISA, qPCR, and flow cytometry.
• Perform sing 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 sing 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.

Requirements

• BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline withBS with 3–5 years of GMP sing experience or MS with 1–3 years of GMP sing 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).