Director - Biologics Process Translation & Execution Lilly Medicine Foundry

Eli Lilly Eli Lilly · Pharma · Lebanon, IN

Director level role in Eli Lilly's Medicine Foundry, focused on advanced manufacturing and drug development for biologics and other modalities. The role involves leading a team of scientists and engineers to drive scientific excellence, accelerate manufacturing advancements, oversee technology transfer, implement control strategies, and ensure right-first-time clinical manufacturing. It requires technical oversight, documentation, risk mitigation, process stewardship, deviation investigations, and collaboration with cross-functional teams and external partners. The role also involves defining and leading the site's technical innovation strategy for manufacturing capabilities.

What you'd actually do

  1. Guide, mentor, and supervise a team of PTE scientists and engineers, provide technical expertise and guidance throughout all project phases.
  2. Provide technical oversight for clinical DS process technology transfer activities from Process Development to Foundry cGMP Operations; leverage deep process understanding to guide successful tech transfer, ensure right-first-time execution.
  3. Serve as the primary Subject Matter Expert (SME) for clinical API manufacturing processes, providing scientific and technical support to front line process teams and operations on the manufacturing floor.
  4. Define and lead Foundry’s technical innovation strategy, identifying and implementing next-generation capabilities to support new clinical assets and evolving portfolio needs.
  5. Act as a key technical liaison and project leader for cross-functional teams, including Process Development, Engineering, Analytical, Quality, Supply Chain and Raw Materials, and Regulatory Affairs.

Skills

Required

  • PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related field
  • Experience in biologics process development and manufacturing
  • Experience in technology transfer
  • Experience in clinical manufacturing
  • Experience in leading and mentoring technical teams
  • Strong understanding of cGMP operations
  • Excellent technical documentation skills
  • Risk analysis and mitigation strategies
  • Cross-functional collaboration

Nice to have

  • Experience with synthetic molecules, peptides, oligonucleotides, and bioconjugates
  • Knowledge of emerging technologies in manufacturing
  • Experience with regulatory inspections/audits