Advisor – Process Engineer. Lilly Medicine Foundry

Responsibilities

• Under the direction of the Process Engineering leadership, the Advisor – Process Engineer:
  • Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participates in the establishment and maintenance of the Foundry's Quality systems.
    • Serves as the technical authority for equipment design and scale-up calculations across the Foundry's small molecule node, spanning both established and emerging modalities.
    • Typical responsibilities include: Leading detailed engineering calculations, heat and mass transfer modeling, and equipment sizing to support the design of production suites for small molecule, peptide, oligonucleotide, and other new modality processes.
    • Performing and directing rig-fit assessments for incoming processes, using process simulation tools (e.g., DynoChem, Aspen) to validate that reactor geometries, mixing performance, heat transfer, and pressure ratings are appropriate for scale-up to the kilo lab and pilot plant.
    • Providing expert guidance on the selection and design of reactor systems for a diverse range of chemistries, including batch and semi-batch reactions, continuous flow unit operations, hydrogenation (fixed-bed, slurry, and high-pressure systems), peptide synthesis reactors (SPPS), and oligonucleotide synthesis platforms.
    • Driving scale-up from laboratory and kilo lab to full pilot plant production, ensuring heat and mass transfer, mixing, and process safety considerations are rigorously evaluated and documented at each scale transition.
    • Leading P&ID reviews for relevant design packages and communicating design intent and basis across engineering disciplines, vendors, and partner functions.
    • Developing and maintaining manufacturing processes and control strategies for drug substance APIs, with particular emphasis on translating development-scale chemistry into fit-for-purpose equipment specifications.
    • Providing expert guidance on the preparation of manufacturing and controls sections of INDs, CTX filings, regulatory submissions, and annual updates.
    • Authoring and ensuring timely completion of high-quality technical reports, basis-of-design documents, and engineering specifications.
    • Ensures records and technical notebooks are adequately maintained.
  • Demonstrates the Lilly Leadership behaviors, as defined in the Lilly Performance Management system.
  • Plans and manages short-term and long-term development activities within the Process Engineering function.
  • Assigns work, coordinates efforts, evaluates progress, and reviews the activities of engineers and scientists assigned to the group.
  • Develops and reviews plans and timetables for project work.
  • Recommends resource allocation to accomplish projects according to plans, communicates progress, and proposes changes to project timetables, objectives, or direction.
  • Takes a leadership role in ensuring departmental compliance with all applicable laws, regulations, guidelines, procedures, and practices governing drug research and development, including departmental and corporate standard operating procedures, good manufacturing practices, and safety procedures.
  • Provides active engagement and communication with cross-functional partners including HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, and Manufacturing.
  • Ensures that people and their environment are safe and that company policies concerning safety are followed.
  • Leads and participates in Process Hazard Reviews, HAZOPs, thermal hazard assessments, and other safety evaluations applicable to high-pressure, flammable, and novel modality processes.
  • Trains and mentors process engineers at all levels on equipment design principles, scale-up methodologies, GMP procedures, and Foundry-specific technical requirements across modalities.

Qualifications

• PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related discipline.
• OR B.S. or M.S. in Chemical Engineering or a related discipline with 10+ years of experience in pharmaceutical, biotech, or CMO process engineering supporting drug substance API development or manufacturing.