Scientist Process Analytical Technologies Lilly Medicine Foundry

Lilly Medicine Foundry Process Analytical Technology Scientist

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.

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.

In the Project Delivery Phase and Startup Phase of the project (2025 to 2028), 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. This will require significant collaboration, creativity and resilience as the Lilly Medicine Foundry goes from design, to start-up, and to steady-state operations.

The Process Analytical Technology Scientist role, a technical-track position, seeks a collaborative, inclusive, and energetic Process Analytical Technology (PAT) scientist who will participate in the installation and execution of PAT strategies to be utilized at the Lilly Medicine Foundry to support the production of synthetic and biologic drug substance processes. This role will collaborate with the parent CMC development organizations to understand the needs of the portfolio and PAT to be implemented in production.

The Lilly Medicine Foundry, a state-of-the-art facility, will utilize the latest in automation to further the analytical capabilities including on-line in-process control testing through material release and on-going process monitoring at the site.

The PAT group will consist of high-level scientists focused on the implementation of new technologies and analytical process improvements. This position involves working cross-functionally within the site and across the network to develop strategic functional capabilities and will ensure appropriate capacity, capabilities and business processes are developed, implemented and sustained to deliver the required information to the project teams. This position will be key to ensuring a strong safety culture and establishing a safety, quality and continuous improvement focused mindset within the organization.

Responsibilities:

• Drive implementation of technical solutions and analytical strategies via PAT to enable drug substance production at the Lilly Medicine Foundry.
• Investigate the feasibility of instruments to use for in-line monitoring. Ensure methods are technically sound, well developed, and fit-for-purpose.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, PAT, and modeling and simulation).
• Support automation development (i.e., integrated control systems) between PAT tools and process data systems (i.e., synTQ or other systems).
• Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
• Welcome varied perspectives to create new solutions.
• Coordinate instrumentations between different projects to allow equal usage of available tools for project specific needs.
• Author or contribute to technical documents including SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
• Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP and GMP requirements.

Basic Requirements:

• B.S. in chemistry, chemical engineering, or related field
• Experience with using analytical equipment in regulated industrial environment
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Preferences:

• Experience with product development,…