Principal Scientist Reference Standards Lilly Medicine Foundry
Eli Lilly and Company
June 26, 2026
On-site
Indianapolis, IN
Operations
Principal Scientist, Reference Standards
Responsibilities:
- Own qualification/characterization of site primary, working, impurity, and system suitability reference standards using orthogonal techniques (identity, purity, assay, impurity profiling, bioassay/relative potency). Assign potency with documented expiry/retest justification; approve data packages as technical SME.
- Lead two-tier (primary/working) qualification program, including bridging to compendial and WHO standards for biologics (protocol/report approval, stability design, re-evaluation, procurement, storage, inventory, expiry/retest tracking, COA review).
- Source approved corporate standards; complete site-specific bridging/receipt verification; document linkage to corporate-qualified lot.
- Perform lot-to-lot bridging and trigger requalification when needed; coordinate with Regulatory Affairs on impacts to filed methods.
- Lead investigations/deviations for reference standards; author reports; drive root cause analysis; partner with QA on CAPA.
- Author change controls for SOPs, qualification protocols, specs, and test methods aligned with USP, ICH Q6, and Lilly Quality Standards; assess release/stability impact; define implementation/verification.
- Serve as site SME for internal audits and regulatory inspections (FDA, EMA, others).
- For biologics: qualify bioassay reference materials/control samples; maintain calibration hierarchy; manage frozen aliquots/freezing limits; align to WHO International Standards where applicable.
- Trend qualification/stability data; contribute to regulatory submissions.
- Drive continuous improvement of qualification workflows/characterization strategies and digital systems (LIMS, ELN, LabVantage, automation).
- Ensure ALCOA+ data integrity and compliance with 21 CFR Part 11 and data governance for all reference standard records.
- Support raw material release testing as needed.
Basic Requirements:
- BS or MS in chemistry, biochemistry, pharmaceutical sciences, biology, or related.
- BS: 5–10 years experience OR MS: 5+ years authoring change controls/investigations and owning/leadin g reference standard qualification/characterization/lifecycle management.
- Authorization to work in the U.S. full-time; no visa sponsorship.
Additional Preferences (skills):
- Orthogonal characterization techniques (HPLC/UPLC, GC, LC-MS/GC-MS, NMR incl. 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; chromatography data systems (Empower, Chromeleon).
- Knowledge of USP/Ph. Eur 5.12/JP, ICH Q6A/Q6B/Q7, and 21 CFR 211.194 for reference standard qualification/lifecycle.
Other Information (role conditions):
- Initial at Parkwood West and/or Lilly Technology Center; permanent at Lilly Medicines Foundry in Lebanon, IN.
- First shift with occasional off-shift/weekend/holiday coverage.
- Travel <5% domestic.
- Ability to handle hazardous chemicals/solvents in PPE; extended standing; gowned lab work.
Responsibilities:
- Own qualification/characterization of site primary, working, impurity, and system suitability reference standards using orthogonal techniques (identity, purity, assay, impurity profiling, bioassay/relative potency). Assign potency with documented expiry/retest justification; approve data packages as technical SME.
- Lead two-tier (primary/working) qualification program, including bridging to compendial and WHO standards for biologics (protocol/report approval, stability design, re-evaluation, procurement, storage, inventory, expiry/retest tracking, COA review).
- Source approved corporate standards; complete site-specific bridging/receipt verification; document linkage to corporate-qualified lot.
- Perform lot-to-lot bridging and trigger requalification when needed; coordinate with Regulatory Affairs on impacts to filed methods.
- Lead investigations/deviations for reference standards; author reports; drive root cause analysis; partner with QA on CAPA.
- Author change controls for SOPs, qualification protocols, specs, and test methods aligned with USP, ICH Q6, and Lilly Quality Standards; assess release/stability impact; define implementation/verification.
- Serve as site SME for internal audits and regulatory inspections (FDA, EMA, others).
- For biologics: qualify bioassay reference materials/control samples; maintain calibration hierarchy; manage frozen aliquots/freezing limits; align to WHO International Standards where applicable.
- Trend qualification/stability data; contribute to regulatory submissions.
- Drive continuous improvement of qualification workflows/characterization strategies and digital systems (LIMS, ELN, LabVantage, automation).
- Ensure ALCOA+ data integrity and compliance with 21 CFR Part 11 and data governance for all reference standard records.
- Support raw material release testing as needed.
Basic Requirements:
- BS or MS in chemistry, biochemistry, pharmaceutical sciences, biology, or related.
- BS: 5–10 years experience OR MS: 5+ years authoring change controls/investigations and owning/leadin g reference standard qualification/characterization/lifecycle management.
- Authorization to work in the U.S. full-time; no visa sponsorship.
Additional Preferences (skills):
- Orthogonal characterization techniques (HPLC/UPLC, GC, LC-MS/GC-MS, NMR incl. 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; chromatography data systems (Empower, Chromeleon).
- Knowledge of USP/Ph. Eur 5.12/JP, ICH Q6A/Q6B/Q7, and 21 CFR 211.194 for reference standard qualification/lifecycle.
Other Information (role conditions):
- Initial at Parkwood West and/or Lilly Technology Center; permanent at Lilly Medicines Foundry in Lebanon, IN.
- First shift with occasional off-shift/weekend/holiday coverage.
- Travel <5% domestic.
- Ability to handle hazardous chemicals/solvents in PPE; extended standing; gowned lab work.