Principal Scientist Raw Materials Lilly Medicine Foundry
Eli Lilly and Company
June 26, 2026
On-site
Lebanon, IN
Operations
Responsibilities:
- Perform/oversee GMP analytical testing of raw materials (compendial: USP/EP/JP/ChP; non-compendial); provide SME review for accurate/timely disposition.
- Execute lab operations per cGMP, ALCOA+, regulations, and SOPs (data/instrumentation review; lab notebooks).
- Lead investigations for OOS/OOT/atypical results; author reports; support RCA; track CAPAs to closure.
- Support raw material certification program (supplier qualification/requalification; CoA review/correlation; reduced testing eligibility; periodic re-evaluation; maintain certified list/quality agreements).
- Train/mentor junior analysts; assess proficiency; maintain training records/qualification matrices.
- Author change controls for specifications, test methods, and SOPs; support implementation/verification and cross-functional approvals.
- Serve as SME during internal audits/regulatory inspections; respond to inspector questions; support remediation.
- Handle hazardous materials/solvents/reagents per EHS; maintain clean compliant lab (5S/lean).
- Support continuous improvement of methods/workflows and digital systems (LIMS/ELN/LabVantage, automation).
Basic Requirements:
- BS/MS in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related.
- BS 5–10 years or MS 3+ years cGMP analytical lab experience (change controls/investigations, mentoring, raw material certification or supplier qualification).
- Raw materials testing/sampling/release in GMP pharma/biotech.
- Proficiency in Raman, FTIR, UV-Vis, HPLC, GC, Karl Fischer titration, and wet chemistry.
- US work authorization (no visa sponsorship).
Additional Preferences:
- ELN, LIMS, LabVantage, chromatography systems (e.g., Empower/Chromeleon); USP/EP/JP/ICH application; qualification curricula/training plans.
Other Information (role details):
- Locations: initial Indianapolis; permanent Lebanon, IN (Medicine Foundry). Travel <5% domestic. First shift with occasional coverage. Physical: PPE/hazardous chemicals; stand for extended periods.
Benefits:
- Eligible for company bonus (FTE). Comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible spending, life insurance, certain time off/leave, well-being benefits.
- Perform/oversee GMP analytical testing of raw materials (compendial: USP/EP/JP/ChP; non-compendial); provide SME review for accurate/timely disposition.
- Execute lab operations per cGMP, ALCOA+, regulations, and SOPs (data/instrumentation review; lab notebooks).
- Lead investigations for OOS/OOT/atypical results; author reports; support RCA; track CAPAs to closure.
- Support raw material certification program (supplier qualification/requalification; CoA review/correlation; reduced testing eligibility; periodic re-evaluation; maintain certified list/quality agreements).
- Train/mentor junior analysts; assess proficiency; maintain training records/qualification matrices.
- Author change controls for specifications, test methods, and SOPs; support implementation/verification and cross-functional approvals.
- Serve as SME during internal audits/regulatory inspections; respond to inspector questions; support remediation.
- Handle hazardous materials/solvents/reagents per EHS; maintain clean compliant lab (5S/lean).
- Support continuous improvement of methods/workflows and digital systems (LIMS/ELN/LabVantage, automation).
Basic Requirements:
- BS/MS in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related.
- BS 5–10 years or MS 3+ years cGMP analytical lab experience (change controls/investigations, mentoring, raw material certification or supplier qualification).
- Raw materials testing/sampling/release in GMP pharma/biotech.
- Proficiency in Raman, FTIR, UV-Vis, HPLC, GC, Karl Fischer titration, and wet chemistry.
- US work authorization (no visa sponsorship).
Additional Preferences:
- ELN, LIMS, LabVantage, chromatography systems (e.g., Empower/Chromeleon); USP/EP/JP/ICH application; qualification curricula/training plans.
Other Information (role details):
- Locations: initial Indianapolis; permanent Lebanon, IN (Medicine Foundry). Travel <5% domestic. First shift with occasional coverage. Physical: PPE/hazardous chemicals; stand for extended periods.
Benefits:
- Eligible for company bonus (FTE). Comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible spending, life insurance, certain time off/leave, well-being benefits.