Sr. Principal Scientist, Quality Control
Listed on 2026-11-04
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Production QC/QA, Quality Control - QC Analysts/Managers
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.
Organization Overview:
Lilly is currently constructing a cutting‑edge facility for the manufacture of new modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility (LP2) will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products will include next‑generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.
This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, and start up the facility for both clinical and commercial supply.
The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing. The Sr. Principal Chemist is an individual contributor and site subject matter expert (SME) who supports new product introductions, commercialization, and ongoing commercial manufacturing/testing in the LP2 Quality Control laboratory for gene therapy and other advanced therapy products, including those from new acquisitions and internal development streams.
This role executes assays, supports laboratory site readiness, and provides technical expertise during post‑start operations. The Sr. Principal Scientist partners closely with the Site QC Lead and laboratory team members to ensure timely, compliant, and scientifically sound testing delivery.
Responsibilities- Serve as a site SME for gene therapy analytical methods, supporting the Site QC Lead and laboratory team members with technical guidance, troubleshooting, and investigation support.
- Support new product introductions and commercialization in the QC laboratory, including method transfer, qualification, and validation for products originating from new acquisitions and internal development streams.
- Execute assays hands‑on in support of in‑process, release, and stability testing, including routine and non‑routine testing, ensuring data integrity and compliance with GMP requirements.
- Support laboratory site readiness activities, including equipment and method readiness, procedure development, and testing capability build‑out, and provide technical support for post‑start operations and lifecycle management of methods.
- Partner with Technical Services/Manufacturing Science, Analytical Development, Quality Assurance, and external partners to ensure technical alignment and testing readiness for new and existing products.
- Author and review technical documents, including protocols, reports, procedures, and investigations, and support inspection readiness and regulatory inspections as a technical SME, while training and mentoring laboratory team members.
- Bachelor's degree in chemistry, biochemistry, molecular biology, or another related science discipline
- 7+ years of advanced therapy experience in one or more of the following: gene therapy, LVV, LNP, AAV)
- Hands‑on…
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