Advisor - Technical Steward - TSMS

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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. This is a unique opportunity to be a 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.

Main Purpose and Objectives:   

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.  This position 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. 

Key Responsibilities:  

• 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 the management of daily manufacturing operations.  May present process data and analyses with Process Team members at Manufacturing Process Team meetings.  Drives solutions impacting results across sites or function.  

• Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.  Reviews/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 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.  Influences others to adopt a different point of view on difficult concepts.

• 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…