Associate Director - Quality Control, Gene Therapies

Lilly • Lebanon, IN

3d • $124,500 - $202,400

About The Position

Lilly is constructing LP2, a technically advanced manufacturing facility in Lebanon, Indiana, focused on new modalities including gene therapy. The facility is intended to support clinical and commercial supply and will use next-generation manufacturing technologies and advanced data collection and analysis platforms.

The Associate Director role sets quality control strategy for LP2 Advanced Therapies, covering internal laboratory operations and external CDMO or contract laboratory testing for gene therapy and other advanced therapy modalities. The role leads QC laboratory startup and ongoing operations, ensuring the organization can receive, test, and release incoming materials, in-process, release, and stability samples for products manufactured at LP2 or by external partners. The position also supports strategic decisions about laboratory siting, staffing, resourcing, and equipment, partnering with site and global laboratory leaders and external partners to deliver timely, compliant, and inspection-ready testing.

Requirements

• Bachelor's degree in a science field related to chemistry, microbiology, biology, or another science discipline.
• At least 8 years of cGMP commercial manufacturing experience in QC or an associated discipline such as Manufacturing, TS/MS, Quality Assurance, or Engineering.
• At least 8 years of direct laboratory leadership and supervision of QC laboratory personnel.

Nice To Haves

• Knowledge of or experience with advanced therapies, such as gene therapy or viral vectors, including large-molecule and/or viral-vector testing techniques.
• Previous experience managing laboratories and/or starting up new laboratories.
• Proficiency in Root Cause Analysis methodology and other 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.

Responsibilities

• Set site QC strategy for internal and external laboratory operations, ensuring capability to receive, 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 and global laboratory leadership to shape the analytical footprint for current and future program needs.
• Lead LP2 QC startup and ongoing laboratory operations, including day-to-day workload planning, compliance, and interaction with GFD and construction teams during facility build-out.
• Oversee testing performed by external partners for products manufactured by LP2 or third-party manufacturers, ensuring consistent quality standards and effective CDMO and contract laboratory quality oversight.
• Monitor compliance with procedures, methods, and regulatory commitments; lead inspection-readiness activities; and participate in internal audits and external regulatory inspections.
• Develop QC personnel through mentoring, coaching, and career planning, fostering a strong quality culture and cross-functional collaboration.

Benefits

• 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, including 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: Director