Advisor - Purification Process Translation and Execution Lilly Medicine Foundry

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 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.

• Process Transfer and Production Support:
  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.
• 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.
• Continuous Improvement:
  Apply scientific knowledge to troubleshoot production issues, identify areas for improvement, design and conduct lab studies, and implement new technologies or procedures.
• 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, including cell culture, centrifugation, filtration, chromatography, conjugation, and aseptic processing).
• Problem-Solving
  
  Skills:
  
  Proven ability to analyze data, perform root cause analysis, and…