Principal Scientist Reference Standards Lilly Medicine Foundry

About the role

The Principal Scientist, Reference Standards will lead the on-site reference standards program at the Lilly Medicine Foundry. This role involves procuring, qualifying, characterizing, and lifecycle-managing reference standards, collaborating with various departments, and supporting regulatory inspections.

Responsibilities

• Own the qualification and characterization of site primary, working, impurity, and system suitability reference standards using orthogonal techniques.
• Lead day-to-day execution of the two-tier qualification program, including bridging to compendial and WHO standards for biologics.
• 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 necessary.
• Lead investigations and deviations involving reference standards, author reports, and drive root cause analysis.
• 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.
• Qualify bioassay reference materials and control samples, manage calibration hierarchy documentation, 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.
• Ensure data integrity across all reference standard records in compliance with ALCOA+ principles, 21 CFR Part 11, and Lilly data governance standards.
• Support raw material release testing as needed.

Requirements

• Bachelor's or Master's degree in chemistry, biochemistry, pharmaceutical sciences, biology, or a related scientific discipline.
• 5-10 years of experience with a Bachelor's degree, or 5+ years of experience with a Master's degree.

Qualifications

• Proficiency with orthogonal characterization techniques such as HPLC/UPLC, GC, LC-MS/GC-MS, NMR, 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.