Site Analytical 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._

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* Position Overview:

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* The Site Analytical Steward provides day-to-day analytical technical support for the Lilly Houston site as it stands up small molecule and oligonucleotide Drug Substance (DS) testing capability. Working under the technical mentorship of the Analytical Molecule Steward, this role performs hands-on laboratory problem solving, supports investigations of aberrant data and results, and helps build site analytical readiness across both modalities as equipment, methods, and staff come online.

This is a developmental role: the Site Analytical Steward is expected to grow technical depth and independence over time, with the Analytical Molecule Steward providing structured mentorship, training, and oversight. As capability and experience develop, the Site Analytical Steward takes on increasing ownership of routine batch review, investigations, and method support activities at the Houston site. The Site Analytical Steward provides direct mentorship and coaching to QC analysts.

The Site Analytical Steward reviews and supports interpretation of batch results for the laboratory and, as qualification develops, may support the holistic review of analytical results associated with a batch. The role works closely with the Analytical Molecule Steward, TS/MS, and process teams, and helps ensure the site technical agenda is executed at the working level.

Key Objectives/Deliverables:

** Technical Review & Batch Support*
* + Support technical review of individual test data associated with batch release, under the guidance of the Analytical Molecule Steward or other qualified reviewer.

+ As proficiency develops, take on increasing responsibility for review and release of routine batch and stability testing.

** Investigation Support*
* + Support investigations into out-of-spec results and aberrant data, performing root cause analysis under mentorship.

+ Troubleshoot equipment and methods as required, escalating complex technical issues to the Analytical Molecule Steward.

+ Perform investigational testing as directed.

+ Interact effectively with business partners to communicate, resolve issues, and gain a clear understanding of each other's requirements.

** Continuous Improvement*
* + Share technical information and contribute to regulatory and/or technical reports and memos.

+ Support research and evaluation of new technologies as the site builds out its equipment and method portfolio.

** Training & Development*
* + Participate in structured technical mentoring…