Site Analytical Steward - QC
Eli Lilly and Company
August 26, 2026
On-site
Houston, TX
Operations
Position Overview
The Site Analytical Steward provides day-to-day analytical technical support for the Houston site as it stands up small molecule and oligonucleotide Drug Substance (DS) testing capability, performing hands-on problem solving and supporting investigations of aberrant data. The role grows technical depth and independence over time, with mentorship from the Analytical Molecule Steward.
Key Objectives/Deliverables
- Technical Review & Batch Support: Support technical review of test data associated with batch release; increase responsibility for routine batch and stability testing review/release.
- Investigation Support: Support investigations into out-of-spec results; root cause analysis under mentorship; troubleshoot equipment/methods; perform investigational testing; communicate with business partners.
- Continuous Improvement: Contribute to regulatory/technical reports and memos; evaluate new technologies.
- Training & Development: Participate in structured mentoring; support QC training as capability develops; mentor/coaching to QC analysts.
- Deviations & Change Controls: Support review of change controls/deviations; document results in accordance with GMP.
- Site Readiness Support: Support compliant lab operations, SOP/training development, safety programs; communicate effectively; support protocol-driven studies and lead equipment qualification/method transfer during startup (with mentorship).
- Inspection Support: Support inspection readiness as directed.
- Method Support/Benchwork: Support method transfer strategies; benchwork for development/validation/transfer; monitor method/process performance.
Basic Requirements
- BS in a related science field + 3–5 years GMP lab experience.
- Proficiency/strong development in chromatographic, spectroscopic, and/or microbiological assays.
- Ability to work in lab with PPE.
- Understanding of compliance/regulatory expectations (build depth under mentorship).
- Problem-solving/analytical thinking; continuous-improvement mindset in a fast-moving startup.
- Strong communication and ability to receive/apply mentorship.
- Proficiency with computer systems.
- Authorized to work in the US full-time; no visa sponsorship.
Additional Preferences
- Experience with small molecules/oligonucleotides/peptides/proteins.
- Familiarity with cGMP drug substance manufacturing.
- Interest in advancing to a senior analytical steward role.
- Experience/interest in greenfield/startup activities (equipment qualification, method transfer).
Benefits/Compensation (as stated)
- Anticipated wage: $65,250–$169,400; possible company bonus; comprehensive benefits (incl. 401(k), medical/dental/vision, flexible benefits, life insurance, time off, well-being benefits).
The Site Analytical Steward provides day-to-day analytical technical support for the Houston site as it stands up small molecule and oligonucleotide Drug Substance (DS) testing capability, performing hands-on problem solving and supporting investigations of aberrant data. The role grows technical depth and independence over time, with mentorship from the Analytical Molecule Steward.
Key Objectives/Deliverables
- Technical Review & Batch Support: Support technical review of test data associated with batch release; increase responsibility for routine batch and stability testing review/release.
- Investigation Support: Support investigations into out-of-spec results; root cause analysis under mentorship; troubleshoot equipment/methods; perform investigational testing; communicate with business partners.
- Continuous Improvement: Contribute to regulatory/technical reports and memos; evaluate new technologies.
- Training & Development: Participate in structured mentoring; support QC training as capability develops; mentor/coaching to QC analysts.
- Deviations & Change Controls: Support review of change controls/deviations; document results in accordance with GMP.
- Site Readiness Support: Support compliant lab operations, SOP/training development, safety programs; communicate effectively; support protocol-driven studies and lead equipment qualification/method transfer during startup (with mentorship).
- Inspection Support: Support inspection readiness as directed.
- Method Support/Benchwork: Support method transfer strategies; benchwork for development/validation/transfer; monitor method/process performance.
Basic Requirements
- BS in a related science field + 3–5 years GMP lab experience.
- Proficiency/strong development in chromatographic, spectroscopic, and/or microbiological assays.
- Ability to work in lab with PPE.
- Understanding of compliance/regulatory expectations (build depth under mentorship).
- Problem-solving/analytical thinking; continuous-improvement mindset in a fast-moving startup.
- Strong communication and ability to receive/apply mentorship.
- Proficiency with computer systems.
- Authorized to work in the US full-time; no visa sponsorship.
Additional Preferences
- Experience with small molecules/oligonucleotides/peptides/proteins.
- Familiarity with cGMP drug substance manufacturing.
- Interest in advancing to a senior analytical steward role.
- Experience/interest in greenfield/startup activities (equipment qualification, method transfer).
Benefits/Compensation (as stated)
- Anticipated wage: $65,250–$169,400; possible company bonus; comprehensive benefits (incl. 401(k), medical/dental/vision, flexible benefits, life insurance, time off, well-being benefits).