Sr. Principal Scientist, Quality Control

100 Eli Lilly and Company; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Medical benefits

Dental benefits

Vision benefits

Job summary

Eli Lilly and Company is seeking a Sr. Principal Chemist for its LP2 Quality Control laboratory in Lebanon, Indiana. The role focuses on gene therapy analytics, method transfer, validation, and strong GMP testing delivery to support commercial and clinical products.

The candidate will execute assays, ensure data integrity, and collaborate across Technical Services, QA, and external partners to maintain testing readiness and support regulatory inspections.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, molecular biology, or related science.
• 7+ years in advanced therapies such as gene therapy or LVV/LNP/AAV.
• Experience with analytical methods for viral/non-viral vectors and data integrity.

Responsibilities

• Serve as site SME for gene therapy analytical methods with technical guidance.
• Assist method transfer, qualification, and validation for acquisitions and internal programs.
• Execute assays for in-process, release, and stability testing with GMP compliance.
• Support site readiness, equipment and method readiness, and lifecycle management.
• Collaborate with QA, Manufacturing Science, and external partners on testing readiness.
• Prepare and review technical documents and support regulatory inspections.

Skills

Gene therapy analytics

Analytical method transfer

Method validation

Troubleshooting

Data integrity

Education

Bachelor's degree in chemistry/biochemistry/molecular biology

Tools

GMP knowledge

qPCR/ddPCR

ELISA

Capsid characterization

Job description

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 at Lilly. It 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.

Basic Qualifications

• 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)

Additional Skills / Preferences

• Hands‑on experience with analytical testing in these spaces in a commercialization and routine commercial manufacturing environment.
• Previous experience in/ with analytical methods for viral vector (AVV, LVV) and non‑viral vector (LNP, etc) products, e.g., ddPCR/qPCR, ELISA, capsid characterization, and cell‑based potency assays.
• Previous experience in/ with analytical method transfer, qualification, and validation.
• Previous experience in/ with new product introduction or technology transfer, including products from acquired or external programs.
• Previous experience in/ with laboratory or facility start‑up.
• Proficient in Root Cause Analysis methodology and laboratory investigation of deviations and out‑of‑specification results.
• Proven ability to serve as a technical SME and influence cross‑functional teams without direct authority.

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 $66,000 - $171,600.

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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly