Organization and Position OverviewLilly 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.
Responsibilities- 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 Fischer, 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.
Basic Requirements:- 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences: - Working knowledge of ICH guidelines, FDA regulations, and pharmaceutical quality systems.
- Working knowledge of cGMP and data integrity (ALCOA+) principles as applied to GMP analytical laboratory operations.
- Ability to accurately execute approved analytical methods and document testing in ELN, LIMS, and controlled forms within a regulated environment.
- Strong troubleshooting, problem-solving, and critical-thinking skills with analytical instrumentation and methods.
- Effective written and verbal communication, with the ability to collaborate within cross-functional teams.
- Hands-on experience with electronic laboratory notebooks (ELN), LIMS, LabVantage, and chromatography data systems (e.g., Empower).
- Familiarity with USP, EP, JP, and ICH guidelines as applied to GMP analytical testing and product specifications.
- Exposure to laboratory investigations (deviations, OOS/OOT), change controls, or analytical method transfer and qualification activities in a GMP environment.
- Experience working in a cross-functional team alongside Quality Assurance, Manufacturing, and Supply Chain.
- Experience supporting GMP testing across an expanded scope, such as microbiology or related testing, cleaning verification/validation, raw materials, and reference standard testing and qualification.
Other Information:- Initial location at Lilly Technology Center, Indianapolis or Parkwood West, Indianapolis
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Location: Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
- Travel: 0 to 10%
- Shift: First shift with occasional off-shift, weekend, or holiday coverage to support manufacturing demand.
- Physical: Ability to handle hazardous chemicals and solvents while wearing required PPE, stand for extended periods, and perform laboratory work in a gowned environment. You should generally be comfortable lifting ~25-30 lb routinely and up to ~40-50 lb occasionally (often with assistance).
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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