Analytical Technical Steward-Small Molecule
Eli Lilly and Company
August 21, 2026
On-site
Indianapolis, IN
Operations
Responsibilities:
- Technical review, interpretation, and release of data (CM data, stability, process validation, reference standard characterization).
- Lead or perform in-depth investigations for OOS results and aberrant data; conduct root-cause analysis; recommend solutions to prevent recurrence.
- Develop investigational testing protocols and perform/oversee required testing.
- Contribute to APR, tech transfer, and process validation.
- Communicate effectively with internal and external customers/business partners.
- Participate in internal/external audits as needed.
- Develop and ensure execution of quality plan projects; coordinate testing across sites for batch release/stability/validation.
- Perform method assessments; ensure method validation packages meet regulatory and compendial monograph expectations.
- Participate in method validation per Global Quality Standards; review analytical test method packages; approve protocols and changes/new methods.
- Provide QC lab support for marketed products (method development/validation/improvements, training/transfer, change controls, regulatory submissions).
- Support technical agenda projects; improve QC assays (variability reduction, optimization, new method development).
- Own local/global method change control; oversee reference standard evaluations; support corporate reference standard characterization.
- Participate in data-integrity review for reference standards; manage method transfers to CMs/third-party QC labs; monograph review/implementation; ensure consistent practices across labs; manage multiple projects.
Qualifications:
- Bachelor’s in a science field (e.g., Chemistry, Biochemistry, Pharmacy).
- 5+ years pharmaceutical GMP lab experience.
- Authorized to work in the US full-time; no sponsorship/visa support.
Preferred/Skills:
- Proficiency in complex analytical testing (HPLC/GC, spectroscopic methods, KF, particle size, LOD, appearance, compendial tests).
- Strong data integrity/compliance knowledge (ALCOA++).
- Root cause analysis skills; strong written/oral communication.
- Experience with method qualification, validation, and transfer; QC support for small-molecule APIs/intermediates/starting materials.
- Proficient with GMP/CS analytical equipment and CSV; experience maintaining corporate reference standards and managing CM testing/reporting.
Additional info:
- Day shift; may require shift support.
- Up to ~20% international travel; passport required.
- Technical review, interpretation, and release of data (CM data, stability, process validation, reference standard characterization).
- Lead or perform in-depth investigations for OOS results and aberrant data; conduct root-cause analysis; recommend solutions to prevent recurrence.
- Develop investigational testing protocols and perform/oversee required testing.
- Contribute to APR, tech transfer, and process validation.
- Communicate effectively with internal and external customers/business partners.
- Participate in internal/external audits as needed.
- Develop and ensure execution of quality plan projects; coordinate testing across sites for batch release/stability/validation.
- Perform method assessments; ensure method validation packages meet regulatory and compendial monograph expectations.
- Participate in method validation per Global Quality Standards; review analytical test method packages; approve protocols and changes/new methods.
- Provide QC lab support for marketed products (method development/validation/improvements, training/transfer, change controls, regulatory submissions).
- Support technical agenda projects; improve QC assays (variability reduction, optimization, new method development).
- Own local/global method change control; oversee reference standard evaluations; support corporate reference standard characterization.
- Participate in data-integrity review for reference standards; manage method transfers to CMs/third-party QC labs; monograph review/implementation; ensure consistent practices across labs; manage multiple projects.
Qualifications:
- Bachelor’s in a science field (e.g., Chemistry, Biochemistry, Pharmacy).
- 5+ years pharmaceutical GMP lab experience.
- Authorized to work in the US full-time; no sponsorship/visa support.
Preferred/Skills:
- Proficiency in complex analytical testing (HPLC/GC, spectroscopic methods, KF, particle size, LOD, appearance, compendial tests).
- Strong data integrity/compliance knowledge (ALCOA++).
- Root cause analysis skills; strong written/oral communication.
- Experience with method qualification, validation, and transfer; QC support for small-molecule APIs/intermediates/starting materials.
- Proficient with GMP/CS analytical equipment and CSV; experience maintaining corporate reference standards and managing CM testing/reporting.
Additional info:
- Day shift; may require shift support.
- Up to ~20% international travel; passport required.