Advisor - Technical Steward - TSMS

Position Overview

This position is part of the Technical Services & Manufacturing Sciences (TSMS) function and is responsible for stewardship and site transfer of commercial molecules, as well as commercialization support for new molecules. It will interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments, and may interact with other Lilly site/contract producers.

• Provides technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility. If necessary, leads the technical transfer of processes from one production facility to another, anticipating and addressing complex scale‑up issues.
• Provides mentorship and scientific expertise to Process Team members monitoring, trending, and analyzing production data. Applies process knowledge and data analysis skills to support daily manufacturing operations, and may present data and analyses in Manufacturing Process Team meetings. Drives solutions impacting results across sites or functions.
• Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies. Reviews and approves Annual Product Review and presents annual Global Product Assessment for stewarded molecule(s).
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves key technical or operational problems that impact the function or geography. Communicates issues in a timely manner. May lead process‑related investigations and assess technical impact. Influences complex regulatory or technical issues within the TSMS area/function.
• Writes standard operating procedures as they relate to the activities of the TSMS group. Reviews and approves manufacturing batch records and other manufacturing documentation.
• Works with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor. Assists in process‑related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.
• As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps define and implement medium to large continuous improvements to manufacturing processes.
• Works with Manufacturing to support the start‑up and validation of new facilities and associated process equipment. Helps define and implement control strategies for Lilly Houston processes.
• Leads post‑launch technical agendas and delivers projects that drive substantial step changes in Manufacturing.
• Assists in planning and execution of process validation activities as required.
• Assists in implementation of medium to large process‑related change controls with greater risk, resource, financial requirements, or complexity as required.
• Builds relationships with internal and external partners, making decisions that impact a function or geography.
• Ensures all job responsibilities are performed in compliance with safety and regulatory expectations as well as cGMP.

• Minimum of 10 years of experience in cGMP small molecule, peptide, or oligonucleotide API commercial‑scale manufacturing. Lesser years may be considered in extraordinary circumstances with proven high‑level performance.
• Bachelor’s degree required; master’s or PhD preferred.
• Process and equipment knowledge of chemical synthesis of active pharmaceutical ingredients.
• Thorough understanding of GMP requirements for a large‑scale manufacturing facility.
• Demonstrated leadership skills.
• Excellent communication skills, both oral and written.
• Authorized to work in the United States on a full‑time basis. Lilly will not sponsor work authorization or visas for this role.

• Experience with process validation, cleaning validation, and…