Sr. Principal Scientist, Quality Control

Regulatory Jobs; Lebanon (IN); On-site; USD 66,000 - 97,000; Full time

Benefits offered by this job

Company bonus

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Job summary

Lilly is building a cutting-edge facility in Lebanon, Indiana, to manufacture gene therapy and advanced therapy products. The Sr. Principal Chemist supports QC labs, develops analytical methods, and ensures readiness for post-start operations.

You will execute assays, transfer methods, and troubleshoot issues while partnering with Quality Assurance, Manufacturing Science, and external partners to ensure timely, compliant testing delivery. Compensation reflects senior-level responsibilities.

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.

Responsibilities

• Serve as a site SME for gene therapy analytical methods and provide technical guidance.
• Support method transfer, qualification, and validation for new acquisitions and internal development streams.
• Execute assays in in-process, release, and stability testing with data integrity and GMP compliance.
• Support site readiness, equipment/method readiness, and lifecycle management of methods.
• Collaborate with cross-functional teams to align testing strategies for new and existing products.
• Author/review technical documents and support inspections as a SME; mentor lab staff.

Skills

Analytical testing

Gene therapy methods

qPCR/ddPCR

ELISA

Capsid characterization

Cell-based potency assays

Root Cause Analysis

Technical SME

Cross-functional influence

Education

Bachelor's degree in chemistry/biochemistry/molecular biology or related science

Tools

ddPCR/qPCR

ELISA

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 - $96,800.

In addition, Lilly offers a comprehensive benefit program to eligible employees:

• Full-time equivalent employees also will be eligible for a company bonus (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 (e.g., 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 (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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