Sr. Director - GMP Operations Project Management

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. We are currently developing several novel drug delivery systems to serve our patients and make lives better.

The Advanced Delivery Systems (ADS) portfolio includes gene editing, in vivo CAR T, and vaccine technologies. These programs span RNA, lipid nanoparticle (LNP), and cell and gene therapy modalities, and they advance through close collaboration among R&D, CMC, Quality, and Supply Chain teams and a network of external partners. This role is central to keeping that work on track by connecting vendors, internal teams, and leadership.

We are seeking an experienced GMP manufacturing project manager to lead integrated planning and execution of non-viral drug product manufacturing activities across multiple external CDMOs and Lilly internal manufacturing sites. This individual will develop and manage cross-functional GMP project plans encompassing technology transfer, manufacturing readiness, materials, production, analytical testing, quality review, release, and delivery. The role will connect internal technical and functional teams with manufacturing-site teams, identify dependencies and risks, facilitate timely decisions, and drive mitigation and recovery plans to support reliable delivery of GMP materials.

The successful candidate will have strong experience managing complex manufacturing programs in a cGMP environment and working across CMC, Manufacturing, Quality, Supply Chain, Regulatory, and program teams.

• Serve as the GMP project management lead for drug product manufacturing activities conducted across multiple CDMOs and Lilly internal manufacturing sites.
• Develop, maintain, and drive integrated project plans covering technology transfer, manufacturing readiness, production, analytical testing, quality review, release, and delivery.
• Coordinate cross-functional planning among CMC, Manufacturing, Quality, Supply Chain, Regulatory, and program teams.
• Establish clear milestones, dependencies, decision points, critical paths, and accountable owners across internal functions and manufacturing sites.
• Lead manufacturing readiness reviews to confirm alignment on materials, methods, documentation, equipment, scheduling, testing, and release activities.
• Facilitate recurring project-team and manufacturing-site meetings, document decisions and actions, and ensure timely closure of commitments.
• Identify schedule, technical, quality, supply, and resource risks that could affect GMP execution or material availability.
• Develop and drive mitigation, contingency, and recovery plans in partnership with the accountable technical and functional leads.
• Coordinate cross-site dependencies where drug substance, drug product, testing, packaging, release, or other…