Associate Director - Biologics Operations – Lilly Medicine Foundry

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Associate Director – Biologics Operations is directly responsible for managing the day-to-day manufacturing operations in the Biologics building and provides oversight for the operational resources assigned to the execution team. The role is responsible for the leadership of frontline leaders in direct execution of manufacturing instructions (e.g., batch production record, SOPs, etc.) to safely and compliantly manufacture high-quality medicine. The role serves as the key integrator of the cross-functional team to drive safety, quality, and continuous improvement in pursuit of Operational Excellence.

The Associate Director – Biologics Operations provides leadership, acts as a key integrator, has accountability for the cross functional execution team, and ensures that appropriate staffing is in place.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), leadership roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

• Build and promote a strong Safety and Quality culture. Maintain a safe working environment and conduct production activities in a manner that protects safety, environment and quality.
• Ensure consistency of operations across shifts through active engagement on the production floor.
• Own the implementation of the change and improvement agenda for the assigned area, ensuring cross functional support and integration.
• Set objectives and development plans for Operations staff, including Operations Leaders and Operators.
• Manage events as required, ensuring appropriate communication within the team and with external teams. Provide input and approve investigations.
• Ensure that team members are appropriately trained, and that operating procedures and training material are available and current.
• Ensure regulatory compliance and operational excellence by supporting lean principles.
• Participate in development and delivery of the medium- and long-term strategic direction for the site.
• Ensure Biologics operations remain compliant with all applicable regulatory requirements. (e.g. Safety, Quality/cGMP, Environmental, Financial, Legal, HR.)
• Support site governance through participation, influence and leadership in cross functional meetings and initiatives.

• During startup, leadership will be collaborative, inclusive, and support the broader team to attract, hire and onboard a significant number of top talent to the Foundry team.
• Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
• Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge and external learning.
• Ability to work…