Advisor - Purification Process Translation and Execution 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.

Organization And Function Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a pioneering center that integrates advanced manufacturing and drug development. As the first facility of its kind, the Foundry is designed to accelerate innovation in manufacturing processes, expand capacity for clinical trial medicines, and speed Lilly innovative medicine to Clinics, and reduce both costs and environmental impact.

The Process Translation and Execution (PTE) team plays a critical role in this mission. PTE is responsible for leading technology transfers from lab or pilot scale to cGMP production, collaborating with Operations and cross-functional teams to ensure reliable clinical supply and right-first-time production. The team also drives continuous improvement, advances the site technical agenda, and research transformative technologies and champions the accelerated adoption of innovation in clinical and commercial manufacturing, ultimately delivering patient-centric outcomes.

We are seeking enthusiastic scientists and engineers to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life.

• Process Transfer and Scale-Up:
  Oversee the successful transfer of API/DS processes from development to Foundry with a focus on purification and flexibility in supporting multiple modalities, including Biologics, ADCs, Tides, ensuring process fit to plant, scalability, and right-first-time execution.
• Continuous Improvement:
  Apply scientific knowledge to troubleshoot production issues, identify areas for improvement, design and conduct lab studies, and implement new technologies or procedures.
• Data Analysis and Reporting:
  Monitor manufacturing processes, analyze experimental and production data, and author technical reports, protocols, and change controls.
• Documentation and Compliance:
  Support the creation and review of technical documents, batch records, process descriptions, and risk assessments, ensuring adherence to cGMP and regulatory standards.
• Cross-Functional Collaboration:
  
  Work closely with various functions within Foundry and across PRD/CMC to achieve project goals and ensure product quality.
• Investigations and CAPA Support:
  Lead or assist in process-related investigations, assess deviations, design and conduct needed lab studies, and support Corrective and Preventive Actions (CAPAs) to maintain product quality and timelines.
• Technical Expertise:
  Provide scientific input during audits, provide on-floor support for critical operations, and mentor or supervise junior scientists or technicians in laboratory procedures, data analysis and related PTE activities.
• Site Technology Agenda & Innovation:
  Collaborate with PRD, Process Engineering, and leverage internal/external/academic partnerships to accelerate innovation, including scouting, assessing, developing, and implementing new technologies. Collaborate with Tech Lilly and Digital Innovation to contribute to identification and implementation of transformative technologies and methodologies to accelerate technology transfer, minimize translation errors, and drive continuous improvement.

• Education:
  
  BS, MS or PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines
• Experience:
  
  BS with 15+ years, or MS with 10+ years, or PhD with 4+ years in Biologics/Drug Conjugates Product/Process Development, Manufacturing Technical Services, or related functional roles

• Technical Expertise:
  Strong knowledge of bioprocesses (upstream or downstream,…