Associate Director/Director - Quality Control, Gene Therapies

About the Role

This is a unique opportunity to be part of the team for the startup of a greenfield manufacturing site at Lilly’s new, cutting-edge facility in Lebanon, Indiana (LP2). The Associate Director (AD) will lead the Quality Control Laboratory, providing direction for both the start-up project phase and operational areas. The role involves designing and executing daily workload planning, ensuring compliance, and serving as a liaison between site leadership and global laboratory leadership. The AD will oversee laboratory testing performed by external partners and ensure the laboratory is capable of handling gene therapy samples for products manufactured at LP2 or by third parties. Flexibility, agility, and right-sizing laboratory processes within global harmonization will be critical for success.

Responsibilities

• Proactively manage day-to-day laboratory operations, including interactions with GFD, construction teams, and internal teams for start-up and testing execution.
• Oversee personnel, including production planners, sample submitters, analysts, and cross-functional groups to maintain laboratory workload and throughput.
• Maintain a high-level understanding of laboratory processes and provide site leadership with insights on capacity, capability, and forward planning for current and new products.
• Develop career plans for laboratory subject matter experts (SMEs), project managers, analysts, and technicians.
• Monitor and ensure compliance with procedures, methods, and regulatory commitments.
• Provide technical understanding of regulations applicable to laboratory testing and sampling for cGMP purposes.
• Participate in internal audits and external inspections.
• Support LIMS usage, implementation, and deployment with strategic oversight.
• Utilize technical skills to investigate out-of-spec results and aberrant data.
• Improve lab quality systems, including developing, reviewing, and approving SOPs and training.
• Contribute to the development and implementation of Global Lab Quality Standards.
• Comply with and implement safety standards.
• Foster a strong quality culture through open communication, teamwork, and employee participation.
• Interact with internal business partners to resolve issues and understand requirements.
• Network with internal and external groups to share best practices, participate in technical planning, and ensure customer needs are met.
• Define and execute inspection readiness activities in the QC laboratories.

Requirements

• Bachelor's degree in a science field related to chemistry, microbiology, biology, or another scientific discipline.
• 5+ years of cGMP commercial manufacturing experience in QC or associated disciplines such as Manufacturing, Technical Services/Manufacturing Science, Quality Assurance, or Engineering.
• 2+ years of direct gene therapy experience.
• 3+ years of experience leading teams.

Preferred Qualifications

• Experience with large molecule and/or viral vector testing techniques.
• Experience managing laboratories or starting up new laboratories.
• Demonstrated strong problem-solving skills and proficiency in Root Cause Analysis methodology.
• Strong interpersonal interaction skills and a focus on continuous improvement.
• Ability to work in a lab environment, including wearing appropriate PPE and adhering to safety considerations.
• Deep understanding of compliance requirements and regulatory expectations.

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits and 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.

Pay

The anticipated wage for this position is $123,000 - $198,000. Full-time equivalent employees are also eligible for a company bonus, depending on company and individual performance.

Lilly is dedicated to supporting individuals with disabilities and ensuring equal opportunities in the workforce. Employee resource groups (ERGs) offer strong support networks and are open to all employees, including groups for Black Employees at Lilly (BE@Lilly), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN), and Women’s Initiative for Leading at Lilly (WILL).