Advisor - Technical Steward - TSMS
Eli Lilly and Company
August 24, 2026
On-site
Houston, TX
$117,000 - $189,200 USD yearly
Operations
Main Purpose and Objectives:
- Part of Technical Services & Manufacturing Sciences (TSMS). Responsible for stewardship and site transfer of commercial molecules and commercialization support for new molecules. Interacts with engineering, manufacturing, validation, QA/QC, development, and regulatory; may interact with other site/contract producers.
Key Responsibilities:
- Provide technical oversight/stewardship for one or more molecules at the Houston facility; lead technical transfer and anticipate complex scale-up issues.
- Mentor Process Team members; monitor, trend, and analyze production data; support daily manufacturing operations and present analyses.
- Author technical reports for process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies; review/approve Annual Product Review and present annual Global Product Assessment.
- Lead resolution of technical issues (control strategy/manufacturing); troubleshoot on the manufacturing floor; lead/assist investigations as needed.
- Write SOPs (TSMS); review/approve manufacturing batch records and related documentation.
- Support process knowledge transfer and training for Manufacturing; gather supporting data on the floor.
- Design/execute/coordinate lab experiments for troubleshooting and continuous improvement; define/implement medium-to-large improvements.
- Support start-up/validation of new facilities and equipment; define/implement control strategies.
- Lead post-launch technical agendas and deliver projects driving substantial manufacturing step-changes.
- Lead/assist process validation planning and execution; own/assist medium-to-large change controls.
- Ensure all responsibilities are performed in compliance with safety and cGMP.
Minimum Requirements:
- 10+ years cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing.
- Bachelor’s required (Master’s/PhD preferred).
- Process/equipment knowledge of chemical synthesis APIs; thorough GMP understanding.
- Demonstrated leadership; excellent oral/written communication.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas.
Additional Preferences:
- Process validation, cleaning validation, and commercialization experience.
Other Information:
- Occasional travel 5–10%; required onsite; required to be on call; shift work may apply.
- Part of Technical Services & Manufacturing Sciences (TSMS). Responsible for stewardship and site transfer of commercial molecules and commercialization support for new molecules. Interacts with engineering, manufacturing, validation, QA/QC, development, and regulatory; may interact with other site/contract producers.
Key Responsibilities:
- Provide technical oversight/stewardship for one or more molecules at the Houston facility; lead technical transfer and anticipate complex scale-up issues.
- Mentor Process Team members; monitor, trend, and analyze production data; support daily manufacturing operations and present analyses.
- Author technical reports for process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies; review/approve Annual Product Review and present annual Global Product Assessment.
- Lead resolution of technical issues (control strategy/manufacturing); troubleshoot on the manufacturing floor; lead/assist investigations as needed.
- Write SOPs (TSMS); review/approve manufacturing batch records and related documentation.
- Support process knowledge transfer and training for Manufacturing; gather supporting data on the floor.
- Design/execute/coordinate lab experiments for troubleshooting and continuous improvement; define/implement medium-to-large improvements.
- Support start-up/validation of new facilities and equipment; define/implement control strategies.
- Lead post-launch technical agendas and deliver projects driving substantial manufacturing step-changes.
- Lead/assist process validation planning and execution; own/assist medium-to-large change controls.
- Ensure all responsibilities are performed in compliance with safety and cGMP.
Minimum Requirements:
- 10+ years cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing.
- Bachelor’s required (Master’s/PhD preferred).
- Process/equipment knowledge of chemical synthesis APIs; thorough GMP understanding.
- Demonstrated leadership; excellent oral/written communication.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas.
Additional Preferences:
- Process validation, cleaning validation, and commercialization experience.
Other Information:
- Occasional travel 5–10%; required onsite; required to be on call; shift work may apply.