Advisor Process Analytical Technologies for Biologics Lilly Medicine Foundry

Eli Lilly Eli Lilly · Pharma · Lebanon, IN

The Process Analytical Technology (PAT) Advisor will lead PAT strategies for biologic drug substance production at the Lilly Medicine Foundry, focusing on implementing and utilizing PAT tools for in-line monitoring and process control. This role involves collaborating with development and manufacturing teams, supporting automation integration, and ensuring cGMP compliance.

What you'd actually do

  1. Drive implementation of technical solutions and analytical strategies via PAT to enable biologic drug substance production at the Lilly Medicine Foundry.
  2. Provide technical leadership for the adoption and use of PAT (e.g., Raman, UV, capacitance) in upstream and downstream biological processes to be executed at the Lilly Medicine Foundry. Investigate the feasibility of instruments to use for in-line monitoring. Ensure methods are technically sound, well developed, and fit-for-purpose.
  3. Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., biochemistry, PAT, and modeling and simulation).
  4. Support automation development (i.e., integrated control systems) between PAT tools and process data systems (i.e., synTQ or other systems).
  5. Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.

Skills

Required

  • Ph.D. in biochemistry, chemical engineering, biochemical engineering or related STEM field; M.S. with 10+ years of experience
  • Background in process analytics with a strong focus on bioprocess analytics, including spectroscopic methods, chromatographic techniques, and/or cell culture monitoring
  • Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization
  • Proven skills developing, validating, and transferring analytical methods
  • Fundamental knowledge of cGMP compliance requirements and cGMP experience

Nice to have

  • Experience with product development, including technical transfer of analytical methods into manufacturing operations
  • Demonstrated ability to drive and accept change
  • Good interpersonal skills and a sustained tendency for collaboration
  • Demonstrated success in persuasion, influence, and negotiation
  • Ability to prioritize multiple activities and manage ambiguity
  • Strong communication (oral, written), organizational, and leadership skills

What the JD emphasized

  • cGMP compliance requirements
  • cGMP experience