Associate Director, Molecule Process Engineering-Lilly Medicine Foundry

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 35,000 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, increase capacity for clinical‑trial medicines, and reduce costs and environmental impact.

The Associate Director Small Molecule Process Engineering provides leadership and direction to the process engineers to ensure that engineering deliverables are sufficiently resourced and qualified to support the Small Molecule production and business agenda. This role is responsible for the productivity and development of process engineers with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacturing of small molecule or peptide products.

Additionally, the Small Molecule Process Engineering Team Leader leads the process engineering organization and influences across functional teams to support the process engineering agenda, business plan priorities, and compliance plan objectives.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), 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 evolves from a design concept to a GMP clinical trial site.

• Responsible for establishing a technically advanced process engineering group through recruitment, supervision, coaching, succession planning and actionable development plans, including performance reviews and development planning.
• Provide process engineering work coordination and guidance to key functional groups and partners.
• Set and reinforce standards for engineering work product and utilization of first principles, and partner with Engineering and across functional teams to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Identify, track, and report key indicators of functional performance.
• Oversee engineering‑related technical issues, improvement initiatives, and technology upgrades; review and approve engineering‑related deviations and change controls.
• Partner appropriately in site planning processes (capital and resource), representing the team’s interests while considering the overall site picture and future portfolio.
• Ensure technical review and approval for documents such as investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, and technical studies.
• Interact with regulators, customers, or other outside stakeholders on business issues or to support internal and external agency audits.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

• Build the organization with the necessary capability, capacity and culture to operate this facility at the highest standards of operational excellence.
• Develop and implement the systems and processes needed to run the site, using existing Lilly knowledge and practices where necessary while incorporating external…