Advisor – Process Engineer. Lilly Medicine Foundry
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-06-26
Listing for:
Initial Therapeutics, Inc.
Full Time
position Listed on 2026-06-26
Job specializations:
-
Engineering
Pharma Engineer, Validation Engineer, Process Engineer, Chemical Engineer
Job Description & How to Apply Below
Overview
The Lilly Medicine Foundry Process Engineering organization is responsible for chemistry, formulation, analytical, and engineering efforts to support development and scale‑up of investigational small molecules. The Advisor – Process Engineer serves as a senior technical authority, providing expert‑level engineering guidance across the full lifecycle of process development, scale‑up, and manufacturing support for the Foundry's small molecule node. This role is part of the startup team for a greenfield manufacturing site and will shape processes, equipment, and engineering culture to enable successful transition to GMP manufacturing.
Responsibilities- Understand and comply with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other regulations, and participate in establishing and maintaining the Foundry's quality systems.
- Serve as technical authority for equipment design and scale‑up calculations across the small molecule node.
- Lead detailed engineering calculations, heat and mass transfer modeling, and equipment sizing for production suites for small molecule, peptide, oligonucleotide, and other new modality processes.
- Perform and direct rig‑fit assessments for incoming processes using simulation tools (e.g., Dyno Chem, Aspen) to validate reactor geometries, mixing performance, heat transfer, and pressure ratings.
- Provide expert guidance on selection and design of reactor systems for batch, semi‑batch, continuous flow, hydrogenation (fixed‑bed, slurry, high‑pressure), peptide synthesis (SPPS), and oligonucleotide synthesis platforms.
- Drive scale‑up from laboratory and kilo‑lab to pilot plant, ensuring heat and mass transfer, mixing, and process safety are rigorously evaluated and documented at each scale transition.
- Lead P & for design packages and communicate design intent across engineering disciplines, vendors, and partner functions.
- Develop and maintain manufacturing processes and control strategies for drug substance APIs, translating development‑scale chemistry into fit‑for‑purpose equipment specifications.
- Provide guidance on preparation of manufacturing and controls sections of INDs, CTX filings, regulatory submissions, and annual updates.
- Author and ensure timely completion of technical reports, basis‑of‑design documents, engineering specifications, and maintain records and technical notebooks.
- Demonstrate Lilly Leadership behaviors as defined in the Lilly Performance Management system.
- Plan and manage short‑term and long‑term development activities within Process Engineering, assigning work, coordinating efforts, evaluating progress, and reviewing activities of engineers and scientists.
- Develop and review plans and timetables for project work; recommend resource allocation; communicate progress; propose changes to project timelines, objectives, or direction.
- Take a leadership role in ensuring departmental compliance with all applicable laws, regulations, guidelines, procedures, and standards.
- Engage and communicate with cross‑functional partners including HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, and Manufacturing.
- Ensure people and environment safety; lead and participate in process hazard reviews, HAZOPs, thermal hazard assessments, and other safety evaluations.
- Train and mentor process engineers at all levels on equipment design principles, scale‑up methodologies, GMP procedures, and Foundry‑specific technical requirements.
- PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline; OR
- B.S. or M.S. in Chemical Engineering or related discipline with 10+ years of experience in pharmaceutical, biotech, or CMO process engineering supporting drug substance API development or manufacturing.
- Deep technical expertise in chemical engineering fundamentals and pharmaceutical process development.
- Strong knowledge and experience in project management within a cross‑functional pharmaceutical development environment.
- Demonstrated leadership capabilities in diverse scientific and engineering teams.
- Good interpersonal…
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