Principal Scientist Reference Standards Lilly Medicine Foundry
Eli Lilly and Company
June 26, 2026
On-site
Lebanon, IN
Operations
Responsibilities
- Own qualification/characterization and lifecycle management of primary/working/impurity/system-suitability reference standards (small molecule & biologics); use orthogonal techniques (identity, purity, assay, impurity profiling, bioassay/relative potency where applicable).
- Lead two-tier (primary/working) qualification including bridging to compendial/WHO standards for biologics; manage protocols/reports, stability design, re-evaluations, procurement, storage, inventory, expiry/retest tracking, and COA review.
- Partner to source corporate standards and complete site-specific bridging/receipt verification and lot linkage.
- Perform lot-to-lot bridging; trigger requalification for drift/usage/timing; coordinate with Regulatory Affairs on method impacts.
- Lead investigations/deviations for reference standards; author reports, drive root cause analysis, and support CAPA.
- Author change controls for SOPs/qualification protocols/specs/test methods aligned with USP/ICH Q6 and Lilly Quality Standards; assess release/stability impact.
- Serve as site SME for internal/regulatory inspections; remediate observations through closure.
- For biologics: qualify bioassay reference materials/control samples; maintain calibration hierarchy; manage frozen aliquots/free/thaw limits; align in-house standards to WHO.
- Trend data, contribute to regulatory submissions; improve workflows and digital systems (LIMS/ELN/etc.); ensure ALCOA+ data integrity (including 21 CFR Part 11).
- Support raw material release testing as needed.
Qualifications (Basic)
- BS/MS in chemistry/biochemistry/pharmaceutical sciences/biology or related field.
- BS with 5–10 years OR MS with 5+ years authoring change controls & investigations and owning/leading reference standard qualification/characterization/lifecycle.
- Full-time US work authorization required; sponsorship not provided.
Preferred Skills
- Orthogonal characterization (HPLC/UPLC, GC, LC-MS/GC-MS, NMR/qNMR, FTIR, UV-Vis, Karl Fischer, ICP-MS/ICP-OES, wet chemistry).
- Biologics characterization (bioassay/relative potency, peptide mapping, CE/iCIEF, intact mass).
- ELN/LIMS/LabVantage/SAP; Empower/Chromeleon; knowledge of USP/Ph. Eur./JP, ICH Q6A/Q6B/Q7, and 21 CFR 211.194.
Benefits
- Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits.
Other Information (Role Logistics)
- Location: Parkwood West and/or Lilly Technology Center; permanent at Lilly Medicines Foundry (Lebanon, IN). First shift with occasional off-shift/weekend/holiday coverage; <5% domestic travel; PPE-required lab work.
- Own qualification/characterization and lifecycle management of primary/working/impurity/system-suitability reference standards (small molecule & biologics); use orthogonal techniques (identity, purity, assay, impurity profiling, bioassay/relative potency where applicable).
- Lead two-tier (primary/working) qualification including bridging to compendial/WHO standards for biologics; manage protocols/reports, stability design, re-evaluations, procurement, storage, inventory, expiry/retest tracking, and COA review.
- Partner to source corporate standards and complete site-specific bridging/receipt verification and lot linkage.
- Perform lot-to-lot bridging; trigger requalification for drift/usage/timing; coordinate with Regulatory Affairs on method impacts.
- Lead investigations/deviations for reference standards; author reports, drive root cause analysis, and support CAPA.
- Author change controls for SOPs/qualification protocols/specs/test methods aligned with USP/ICH Q6 and Lilly Quality Standards; assess release/stability impact.
- Serve as site SME for internal/regulatory inspections; remediate observations through closure.
- For biologics: qualify bioassay reference materials/control samples; maintain calibration hierarchy; manage frozen aliquots/free/thaw limits; align in-house standards to WHO.
- Trend data, contribute to regulatory submissions; improve workflows and digital systems (LIMS/ELN/etc.); ensure ALCOA+ data integrity (including 21 CFR Part 11).
- Support raw material release testing as needed.
Qualifications (Basic)
- BS/MS in chemistry/biochemistry/pharmaceutical sciences/biology or related field.
- BS with 5–10 years OR MS with 5+ years authoring change controls & investigations and owning/leading reference standard qualification/characterization/lifecycle.
- Full-time US work authorization required; sponsorship not provided.
Preferred Skills
- Orthogonal characterization (HPLC/UPLC, GC, LC-MS/GC-MS, NMR/qNMR, FTIR, UV-Vis, Karl Fischer, ICP-MS/ICP-OES, wet chemistry).
- Biologics characterization (bioassay/relative potency, peptide mapping, CE/iCIEF, intact mass).
- ELN/LIMS/LabVantage/SAP; Empower/Chromeleon; knowledge of USP/Ph. Eur./JP, ICH Q6A/Q6B/Q7, and 21 CFR 211.194.
Benefits
- Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits.
Other Information (Role Logistics)
- Location: Parkwood West and/or Lilly Technology Center; permanent at Lilly Medicines Foundry (Lebanon, IN). First shift with occasional off-shift/weekend/holiday coverage; <5% domestic travel; PPE-required lab work.