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. 

Position Overview:

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 provided by the Analytical Molecule Steward.
• Support technical training of QC laboratory personnel as capability develops.

Deviations & Change Controls

• Support review of change controls and observations/deviations.
• Document results of analyses and conclusions accurately and thoroughly in accordance with GMP and local guidelines.

Site Readiness Support

• Support laboratory operations in compliance with applicable procedures and standards as the site stands up.
• Contribute to development of SOPs and training materials as needed.
• Comply with safety standards and support safety programs within the laboratory.
• Communicate effectively in both written and oral formats within the lab and with business partners.
• Support protocol-driven studies (e.g., method validations, investigational studies, method transfers) under guidance.
• Lead execution of equipment qualification and method transfer activities during site startup, in partnership with the Analytical Molecule Steward.

Inspection Support

• Support inspection readiness activities as directed.

Method Support/Benchwork

• Support Site Analytical Transfer Strategies for small molecule and/or oligonucleotide methods under mentorship.
• Perform benchwork in support of method development, validation, and transfer activities.
• Monitor method and process performance for assigned test areas.

Basic Requirements:

• Bachelor's degree in a science field related to the lab (e.g., chemistry, biochemistry, microbiology, or biology) and 3–5 years of relevant experience in a GMP lab.
• Demonstrated proficiency or strong developing skill in laboratory analysis, including chromatographic, spectroscopic, and/or microbiological assays.
• Ability to work in a lab environment, including wearing appropriate PPE and other safety equipment as required.
• Developing understanding of compliance requirements and regulatory expectations, with willingness to build depth under mentorship.
• Demonstrated problem-solving and analytical thinking skills.
• Ability to focus on continuous improvement and to work effectively in a fast-moving site-startup environment.
• Good interpersonal and communication skills; ability to receive and apply mentorship and feedback.
• Proficiency with computer systems.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Exposure to small molecules, oligonucleotide, peptide, or protein analytical testing.
• Familiarity with cGMP requirements in drug substance manufacturing.
• Interest in growing into a more senior analytical steward role over time.
• Experience or interest in supporting greenfield/startup site activities, including equipment qualification and method transfer.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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