Principal Scientist Raw Materials Lilly Medicine Foundry
Eli Lilly and Company
June 26, 2026
On-site
Indianapolis, IN
Operations
Responsibilities:
- Perform/oversee analytical testing of GMP raw materials (compendial and non-compendial); act as SME for analytical data review and disposition.
- Execute lab operations under cGMP, ALCOA+ data integrity, regulations, and SOPs; review data and lab notebooks.
- Lead OOS/OOT/atypical investigations; author reports, support root cause analysis, and track CAPAs to closure.
- Support raw material certification (supplier qualification/requalification, CoA review/correlation, reduced testing eligibility, re-evaluations, certified list maintenance).
- Develop and deliver training for junior analysts; mentor and qualify analysts; support training records/qualification matrices for inspection readiness.
- Author change controls for raw material specs, test methods, and SOPs; assess impacts and support implementation/verification.
- Serve as on-the-bench SME for internal audits and regulatory inspections (e.g., FDA, EMA); support remediation.
- Handle hazardous materials per EHS; maintain compliant lab environment (5S/lean lab practices).
- Partner on continuous improvement 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 laboratory experience; change controls/investigations; mentoring; raw material certification or supplier qualification.
- Raw materials testing/sampling/release in GMP pharma/biotech.
- Proficient in Raman, FTIR, UV-Vis, HPLC, GC, Karl Fischer titration, and wet chemistry.
- Authorized to work in the U.S. full-time; no visa sponsorship/support.
Additional Preferences:
- ELN, LIMS, LabVantage, Empower/Chromeleon.
- Knowledge of USP/EP/JP/ICH guidelines; qualification curricula/training plans.
Other Information:
- Location: initial Indianapolis (Lilly Technology Center or Parkwood West); permanent Lebanon, Indiana (Lilly Medicine Foundry).
- Travel: <5% domestic. Shift: first shift with occasional off-shift/weekend/holiday coverage. Physical: handle hazardous chemicals/solvents with PPE; stand for extended periods; gowned laboratory work.
- Perform/oversee analytical testing of GMP raw materials (compendial and non-compendial); act as SME for analytical data review and disposition.
- Execute lab operations under cGMP, ALCOA+ data integrity, regulations, and SOPs; review data and lab notebooks.
- Lead OOS/OOT/atypical investigations; author reports, support root cause analysis, and track CAPAs to closure.
- Support raw material certification (supplier qualification/requalification, CoA review/correlation, reduced testing eligibility, re-evaluations, certified list maintenance).
- Develop and deliver training for junior analysts; mentor and qualify analysts; support training records/qualification matrices for inspection readiness.
- Author change controls for raw material specs, test methods, and SOPs; assess impacts and support implementation/verification.
- Serve as on-the-bench SME for internal audits and regulatory inspections (e.g., FDA, EMA); support remediation.
- Handle hazardous materials per EHS; maintain compliant lab environment (5S/lean lab practices).
- Partner on continuous improvement 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 laboratory experience; change controls/investigations; mentoring; raw material certification or supplier qualification.
- Raw materials testing/sampling/release in GMP pharma/biotech.
- Proficient in Raman, FTIR, UV-Vis, HPLC, GC, Karl Fischer titration, and wet chemistry.
- Authorized to work in the U.S. full-time; no visa sponsorship/support.
Additional Preferences:
- ELN, LIMS, LabVantage, Empower/Chromeleon.
- Knowledge of USP/EP/JP/ICH guidelines; qualification curricula/training plans.
Other Information:
- Location: initial Indianapolis (Lilly Technology Center or Parkwood West); permanent Lebanon, Indiana (Lilly Medicine Foundry).
- Travel: <5% domestic. Shift: first shift with occasional off-shift/weekend/holiday coverage. Physical: handle hazardous chemicals/solvents with PPE; stand for extended periods; gowned laboratory work.