Senior Process Transfer Scientist – Biologics & ADCs

100 Eli Lilly and Company

Lebanon (IN)

On-site

USD 131,000 - 211,000

Full time

6 days ago
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Job summary

Lilly is seeking enthusiastic scientists and engineers for the Process Translation and Execution team in Indianapolis/Lebanon to lead technology transfers from development to cGMP production. This role focuses on biologics-related transfer, data analysis, and rigorous documentation to ensure right-first-time execution.

Ideal candidates hold BS/MS/PhD in relevant fields with 10+ years for MS or 15+ years for BS in biologics/Drug Conjugates.

Qualifications

  • BS, MS or PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines

Responsibilities

  • 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.
  • Monitor manufacturing processes, analyze experimental and production data, and author technical reports, protocols, and change controls.
  • Support the creation and review of technical documents, batch records, process descriptions, and risk assessments, ensuring adherence to cGMP and regulatory standards.
  • Work closely with various functions within Foundry and across PRD/CMC to achieve project goals and ensure product quality.
  • Lead or assist in process-related investigations, assess deviations, design and conduct needed lab studies, and support CAPAs to maintain product quality and timelines.
  • 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.
  • Apply scientific knowledge to troubleshoot production issues, identify areas for improvement, design and conduct lab studies, and implement new technologies or procedures.
  • 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.

Skills

Bioprocessing
Cell culture
Filtration
Chromatography
Conjugation
Aseptic processing
Data analysis
Root cause analysis
Technical report writing
Cross-functional collaboration
Regulatory knowledge
Project management
Supervisory experience

Education

BS, MS or PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines

Job description

Lilly is seeking enthusiastic scientists and engineers for the Process Translation and Execution team in Indianapolis/Lebanon to lead technology transfers from development to cGMP production. This role focuses on biologics-related transfer, data analysis, and rigorous documentation to ensure right-first-time execution.

Ideal candidates hold BS/MS/PhD in relevant fields with 10+ years for MS or 15+ years for BS in biologics/Drug Conjugates.

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