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 Site QC Lead sets quality control strategy for LP2's Advanced Therapies operations, covering both internal laboratory operations and external CDMO/contract laboratory testing for gene therapy and other advanced therapy modalities. This role provides laboratory leadership during facility startup and ongoing operations, ensuring the QC organization is capable of receipt, testing, and release of incoming materials, in-process, release, and stability samples for products manufactured at LP2 or by external partners. The Site QC Lead supports strategic siting, staffing, and equipment decisions that shape the site's analytical footprint, partnering with site leadership, global laboratory leadership, and external partners to ensure timely, compliant, and inspection-ready testing delivery.
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.
Basic 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 associated disciplines such as Manufacturing, TS/MS, Quality Assurance, or Engineering.
- 8+ years of direct laboratory leadership and supervision of QC laboratory personnel.
Additional Skills/ Preferences:- Knowledge of and/or experience with advanced therapies (e.g., gene therapy, viral vector), including large molecule and/or viral vector testing techniques.
- Previous experience in/ with management of laboratories or start-up of new laboratories.
- Proficient in Root Cause Analysis methodology and other strong problem-solving approaches.
- Proven ability to build strong interpersonal relationships and lead through continuous improvement.
- Prior work with regulatory inspection readiness and inspection execution.
- Deep understanding of compliance requirements and regulatory expectations for GMP laboratory operations.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$124,500 - $202,400
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
