Advisor - Process Translation and Execution – Biologics & Hybrid - Lilly Medicine Foundry

Advisor - Process Translation and Execution – Biologics & Hybrid - 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 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 researches 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.

Key Responsibilities

• Process Transfer and Scale-Up:
  Oversee the successful transfer of new biologics and or bioconjugates processes from development to manufacturing, ensuring scalability and process fit to plant.
• Process Optimization and Improvement:
  Apply scientific knowledge to troubleshoot production issues, identify areas for improvement, 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 departments across CMC, including Product Research and Development, Manufacturing, Quality, to achieve project goals and ensure product quality.
• Investigations and CAPA Support:
  Lead or assist in process-related investigations, assess deviations, and support Corrective and Preventive Actions (CAPAs) to maintain product quality and timelines.
• Technical Expertise and Training/Mentoring:
  Provide scientific input during audits, provide on-floor support for critical operations, and training/mentoring or supervising junior scientists or technicians in laboratory procedures, data analysis and all PTE activities.

Basic Requirements

• 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

Additional Skills And Preferences

• Technical Expertise:
  Strong knowledge of bioprocesses (upstream or downstream), cell culture, bioreactor operation, centrifugation, filtration, chromatography, conjugation, and aseptic processing.
• Problem-Solving Skills:
  Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
• Communication Skills:
  Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
• Collaboration:
  
  Demonstrated success in cross-functional, dynamic, and matrixed environments.
• R…