Advisor - Technical Steward - TSMS

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, Texas. This facility is intended to provide APIs for current and future products, including new modalities. It is a unique opportunity to be part of the startup team for a greenfield manufacturing site, and the successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations.

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. Interaction may be required with other Lilly site/contract producers of Lilly products.

This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real‑world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule or peptides/oligonucleotides.

• Provide technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility. If necessary, lead the technical transfer of processes from one production facility to another, anticipating and addressing complex scale‑up issues.
• Provide mentorship and scientific expertise to Process Team members, monitoring, trending, and analyzing production data. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations. May present process data and analyses with Process Team members at Manufacturing Process Team meetings. Drive solutions impacting results across sites or functions.
• Author technical reports supporting 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 for stewarded molecule(s).
• Lead resolution of technical issues including those related to control strategy and manufacturing.
• Troubleshoot issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipate and resolve key technical or operational problems that impact function or geography. Communicate issues in a timely manner. May lead process‑related investigations and assess technical impact. Influence complex regulatory or technical issues within the TSMS area/function. Influence others to adopt a different point of view on difficult concepts.
• Write standard operating procedures as they relate to the activities of the TSMS group. Review and approve manufacturing batch records and other manufacturing documentation.
• Work with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor. Assist in process‑related training of Manufacturing Process Team members. As required, directly gather additional supporting data on the manufacturing floor.
• As required, design laboratory experiments in support of process troubleshooting and/or continuous improvement and execute or coordinate execution in outside laboratories. Help to define and implement medium to large continuous improvements to manufacturing processes.
• Work with Manufacturing to support the start‑up and validation of new facilities and the associated process equipment. Help to define and implement control strategies for Lilly Houston…