Advisor Process Analytical Technologies Biologics Lilly Medicine Foundry

Position: Advisor Process Analytical Technologies for Biologics 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.

Organization and

Position Overview:

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 Advisor role, a technical-track position, seeks a collaborative, inclusive, and energetic Process Analytical Technology (PAT) scientist who will lead the PAT strategies to be utilized at the Lilly Medicine Foundry to support the production of 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 biologic drug substance production at the Lilly Medicine Foundry.

* Provide technical leadership for the adoption and use of PAT (e.g., Raman, UV, capacitance) in upstream and downstream biological processes to be executed 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., biochemistry, 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).

* Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.

* 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:

* Ph.D. in biochemistry, chemical engineering, biochemical engineering or related STEM field; M.S. with 10+ years of experience. A background in process analytics with a strong focus on bioprocess…