Sr. Principal Scientist, Quality Control

Lilly • Lebanon, IN

18h • $66,000 - $171,600

About The Position

Lilly is constructing LP2, a technically advanced manufacturing facility in Lebanon, Indiana, focused on new modalities including gene therapy. This greenfield site will use next-generation manufacturing technologies and data platforms to support clinical and commercial supply. Its Quality Control laboratory tests products to help ensure patients receive safe and efficacious medicines.

The Sr. Principal Scientist is an individual contributor and site subject matter expert supporting new product introductions, commercialization, and ongoing commercial manufacturing and testing in the LP2 Quality Control laboratory. The role supports gene therapy and other advanced therapy products, including products from acquisitions and internal development. The successful candidate will execute assays, support laboratory readiness, and provide technical expertise during post-start operations, partnering with the Site QC Lead and laboratory team to ensure testing is timely, compliant, and scientifically sound.

Requirements

• Bachelor's degree in chemistry, biochemistry, molecular biology, or another related science discipline.
• At least 7 years of advanced therapy experience in one or more of the following: gene therapy, LVV, LNP, or AAV.

Nice To Haves

• Hands-on analytical testing experience in commercialization and routine commercial manufacturing environments.
• Experience with analytical methods for viral vector (AAV, LVV) and non-viral vector (LNP, etc.) products, such as ddPCR/qPCR, ELISA, capsid characterization, and cell-based potency assays.
• Experience with analytical method transfer, qualification, and validation.
• Experience with new product introduction or technology transfer, including products from acquired or external programs.
• Experience with laboratory or facility start-up.
• Proficiency in Root Cause Analysis methodology and laboratory investigation of deviations and out-of-specification results.
• Ability to serve as a technical subject matter expert and influence cross-functional teams without direct authority.

Responsibilities

• Serve as a site subject matter expert for gene therapy analytical methods, providing technical guidance, troubleshooting, and investigation support to the Site QC Lead and laboratory team.
• Support new product introductions and commercialization in the QC laboratory, including method transfer, qualification, and validation for products from acquisitions and internal development streams.
• Perform in-process, release, and stability assays, including routine and non-routine testing, while ensuring data integrity and GMP compliance.
• Support laboratory site readiness, including equipment and method readiness, procedure development, and testing capability build-out.
• Provide technical support for post-start operations and method lifecycle management.
• Partner with Technical Services/Manufacturing Science, Analytical Development, Quality Assurance, and external partners to align technical work and testing readiness for new and existing products.
• Author and review technical documents, including protocols, reports, procedures, and investigations.
• Support inspection readiness and regulatory inspections as a technical subject matter expert.
• Train and mentor laboratory team members.

Benefits

• Company bonus eligibility for full-time equivalent employees, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal