Sr. Principal Scientist, Quality Control
Eli Lilly and Company
Summary
The Sr. Principal Scientist 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.
Job description
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 with analytical methods for viral vector (AAV, LVV) and non-viral vector (LNP, etc) products, e.g., ddPCR/qPCR, ELISA, capsid characterization, and cell-based potency assays.
- Previous experience with analytical method transfer, qualification, and validation.
- Previous experience with new product introduction or technology transfer, including products from acquired or external programs.
- Previous experience 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.
Requirements
- Bachelor's degree in chemistry, biochemistry, molecular biology, or another related science discipline
- 7+ years of advanced therapy experience in gene therapy, LVV, LNP, or AAV
- Hands-on analytical testing experience in commercialization and routine commercial manufacturing environment
- Experience with analytical methods for viral vector (AAV, LVV) and non-viral vector (LNP) products
- Experience with 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
- Experience with laboratory or facility start-up
- Proficiency in Root Cause Analysis methodology and laboratory investigation of deviations and OOS results
- Ability to serve as a technical SME and influence cross-functional teams without direct authority
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Company bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.