Senior QC Lead, Gene Therapies Startup Lab

Lilly; Lebanon (IN); On-site; USD 125,000 - 202,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical, dental, vision benefits

Vacation benefits

Flexible benefits

Well-being program

Job summary

Lilly is building a state-of-the-art LP2 facility in Lebanon, Indiana, focused on advanced therapies. The Site QC Lead will shape QC strategy for internal and external labs, ensure testing and release of materials, and oversee both startup activities and ongoing operations in a GMP environment.

The role requires 8+ years in cGMP manufacturing with direct QC leadership, plus expertise in inspection readiness and regulatory compliance.

Qualifications

• Bachelor's degree in a science field related to chemistry, microbiology, biology, or another science discipline.
• 8+ years of cGMP commercial manufacturing experience in QC or related disciplines.
• 8+ years of direct laboratory leadership and supervision of QC laboratory personnel.

Responsibilities

• Set site QC strategy for internal and external laboratory operations, ensuring capability to receipt, test, and release incoming materials, in-process, release, and stability samples for products manufactured at LP2 or by external partners.
• Support strategic siting, resourcing, and equipment decisions for the QC organization, partnering with site leadership and global laboratory leadership to size and shape the site's analytical footprint against current and future program needs.
• Provide laboratory leadership for LP2 QC's start-up and ongoing operations, managing day-to-day workload planning, compliance, and interaction with GFD and construction teams during facility build-out.
• Oversee laboratory testing performed by external partners for products manufactured by LP2 or third-party manufacturers, ensuring consistent quality standards and effective CDMO/contract laboratory quality oversight.
• Monitor and ensure compliance to procedures, methods, and regulatory commitments, and lead inspection readiness activities and participation in internal audits and external regulatory inspections.
• Develop QC personnel through mentoring, coaching, and career planning, fostering a strong quality culture and effective cross-functional collaboration.

Skills

Root Cause Analysis

Cross-functional collaboration

Inspection readiness

Leadership

GMP knowledge

Education

Bachelor's degree in a science field

Job description

Lilly is building a state-of-the-art LP2 facility in Lebanon, Indiana, focused on advanced therapies. The Site QC Lead will shape QC strategy for internal and external labs, ensure testing and release of materials, and oversee both startup activities and ongoing operations in a GMP environment.

The role requires 8+ years in cGMP manufacturing with direct QC leadership, plus expertise in inspection readiness and regulatory compliance.