Analytical Molecule Steward - QC

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.  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 40,000 employees around the world 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX.   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 to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Overview: The Analytical Molecule Steward is a senior technical leadership role responsible for building and standing up Drug Substance (DS) analytical capability at the Lilly Houston site — a greenfield API/oligonucleotide manufacturing facility in startup phase. This role leads the technical transfer, method implementation, and analytical control strategy definition needed to introduce oligonucleotide and small molecule DS analytics to Houston, working closely with the site QC team, TS/MS, engineering, and central governance groups to ensure the site is ready to support process validation and commercial manufacturing. Beyond site startup, the Analytical Molecule Steward serves as the network-level analytical steward for assigned molecule(s), with a particular near-term focus on oligonucleotide products as Houston brings its first commercial molecules online. In this capacity, the role owns the analytical control strategy lifecycle for the molecule(s), partners with the TS/MS Molecule Steward and Regulatory representatives, and represents Houston in network-level analytical governance forums. Candidates with commercialization experience — having taken a molecule from development/technical transfer through to commercial release — are strongly preferred, given the dual site-build and molecule-stewardship nature of this role. The Analytical Molecule Steward provides technical mentorship to the Site Analytical Steward and broader QC lab staff, and is expected to be the senior technical voice representing analytical sciences within relevant Houston leadership teams (e.g., the Science/Analytical Leadership Team and, where applicable, the Commercialization Lead Team).

Site Startup & Analytical Control Strategy Lead the technical transfer and startup of DS analytical methods into the Houston site, including defining technical transfer and knowledge-build strategies for oligonucleotide and small molecule modalities. Define and own the analytical control strategy for assigned molecule(s) through each step of the manufacturing process, leveraging knowledge of development, manufacturing, and regulatory expectations. Partner with Technical Services/Manufacturing Science (TS/MS), Engineering, and site leadership to define equipment, method, and