Associate Director - Biologics 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 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 Process Engineering provides leadership and direction to the process engineering team to ensure that engineering deliverables are sufficiently resourced and qualified to support biologics drug substance manufacturing and the broader 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 manufacture of biologic products, including monoclonal antibodies, bioconjugates, and other large molecule modalities.

The Biologics 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 and startup phase of the Lilly Medicine Foundry (startup expected 2025 to 2027), leadership roles will be fluid and dynamic as we endeavor to support 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.

Key Responsibilities

* Responsible for establishing a technically advanced biologics process engineering group. This is achieved through recruitment, supervision, coaching, succession planning, and establishing actionable development plans, inclusive of completing performance reviews and development planning.

* Provide process engineering work coordination and guidance to key functional groups and partners supporting biologics manufacturing operations, including upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations.

* In coordination with the engineering function, set and reinforce standards for engineering work product and utilization of first principles. Partner within Engineering and across functional teams to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.

* Ensure appropriate process engineering support for biologics operations including facility fit assessments, process troubleshooting, scale-up/scale-down support, and continuous process improvements for biologic drug substance manufacturing.

* Oversee engineering-related technical issues, improvement initiatives, and technology upgrades specific to biologics unit operations (e.g., bioreactors, chromatography systems, TFF/UF-DF, sterile filtration, single-use systems). Review and approve engineering-related deviations and change controls.

* Ensure GMP compliance of facilities, processes, and documentation, maintaining the organization in a state of inspection readiness. Ensure all process engineering activities and documentation are performed in alignment with current data integrity requirements.

* Ensure technical review and approval for documents as appropriate, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing records, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, and biologics-specific documents such as process characterization reports and comparability assessments.

* Identify, track, and report key indicators of functional performance.

* Partner appropriately in site planning processes (capital and resource), representing the interests of the team with a view to the overall site picture and future biologics portfolio.

* Serves as System Owner for designated computer, automation, and bioprocess control systems (e.g., bioreactor SCADA, process chromatography systems).

* Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits, including…