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.
We are hiring a Principal Scientist, Reference Standards to own our on-site Reference Standards program end-to-end - the work that makes every analytical result we generate traceable, defensible, and inspection-ready. In this hands-on, bench-engaged role, you will procure, qualify, characterize, and lifecycle-manage the primary and working reference standards (small molecule and biologic) that anchor our clinical and commercial GMP testing. You will work under the direction of the Advisor of Raw Materials and partner closely with Analytical Development, QA, Manufacturing, Regulatory Affairs, and Lilly's Corporate Reference Standards Organization, and you'll be the technical voice for the Lilly Medicine Foundry reference standard program during regulatory inspections.
Responsibilities- Own the qualification and characterization of site primary, working, impurity, and system suitability reference standards using orthogonal techniques - identity, purity, assay, impurity profiling, and bioassay/relative potency where applicable. Assign potency with documented expiry/retest justification and approve the resulting data packages as technical SME for manufacturing and QC schedules.
- Lead day-to-day execution of the two-tier (primary/working) qualification program - including bridging to compendial and WHO standards for biologics - covering protocol/report approval, stability program design, periodic re-evaluation, procurement, storage, inventory, expiry/retest tracking, and COA review.
- Partner with Lilly's Corporate Reference Standards Organization to source approved corporate standards, complete site-specific bridging and receipt verification, and document linkage to the corporate-qualified lot.
- Execute lot-to-lot bridging at standard transitions and trigger requalification when retest dates, analytical drift, or usage patterns warrant it; coordinate with Regulatory Affairs on impact to filed methods.
- Lead investigations and deviations involving reference standards (out-of-spec, out-of-trend, atypical results, storage excursions, freeze/thaw events). Author reports, drive root cause analysis, and partner with QA on CAPA definition and closure.
- Author change controls for SOPs, qualification protocols, specifications, and test methods aligned with USP , ICH Q6, and Lilly Quality Standards. Assess release and stability impact, define implementation and verification, and shepherd cross-functional approval.
- Serve as site SME for reference standards during internal audits and regulatory inspections (FDA, EMA, and others) - back-room preparation, inspector responses, and observation remediation through closure.
- For biologics, qualify bioassay reference materials and control samples, maintain calibration hierarchy documentation, manage frozen aliquots and freeze/thaw limits, and align in-house standards to WHO International Standards where applicable.
- Trend qualification and stability data and contribute technical content to regulatory submissions.
- Drive continuous improvement of qualification workflows, characterization strategies, and digital systems (LIMS, ELN, LabVantage, automation).
- Ensure data integrity across all reference standard records - raw data, qualification packages, stability datasets, and electronic systems - in compliance with ALCOA+ principles, 21 CFR Part 11, and Lilly data governance standards.
- Support raw material release testing as needed.
Basic Requirements:- BS or MS in chemistry, biochemistry, pharmaceutical sciences, biology, or a related scientific discipline
- BS 5-10 years OR MS with 5+ years of experience in authoring change controls and investigations, hands-on experience leading or owning a reference standard qualification, characterization, or lifecycle management program.
- 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: - Proficiency with orthogonal characterization techniques such as HPLC/UPLC, GC, LC-MS/GC-MS, NMR (including qNMR), FTIR, UV-Vis, Karl Fischer, ICP-MS/ICP-OES, and wet chemistry.
- Familiarity with biologics characterization - bioassay/relative potency, peptide mapping, CE/iCIEF, intact mass.
- Experience with electronic laboratory notebooks (ELN),LIMS, LabVantage, SAP for material management, and chromatography data systems (Empower, Chromeleon).
- Working knowledge of USP , Ph. Eur. 5.12, JP, ICH Q6A/Q6B and Q7, and 21 CFR 211.194 as applied to reference standard qualification and lifecycle management.
Other Information:- Initial location at Parkwood West and/or Lilly Technology Center.
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Shift: First shift, with occasional off-shift, weekend, or holiday coverage to support manufacturing demand.
- Travel: Less than 5% domestic.
- Physical: Ability to handle hazardous chemicals and solvents in required PPE, stand for extended periods, and perform laboratory work in a gowned environment.
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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