Responsibilities:
- Serve as technical authority for equipment design and scale-up calculations across the Foundryβs small molecule node.
- Lead detailed engineering calculations, heat/mass transfer modeling, and equipment sizing for production suites (small molecule, peptide, oligonucleotide, and new modalities).
- Conduct and direct rig-fit assessments for incoming processes using simulation tools (e.g., DynoChem, Aspen) to validate scale-up readiness (reactor geometries, mixing, heat transfer, pressure ratings).
- Provide guidance on reactor selection/design for batch/semi-batch, continuous flow, hydrogenation systems, SPPS peptide synthesis reactors, and oligonucleotide synthesis platforms.
- Drive scale-up from lab/kilo lab to pilot plant, ensuring rigorous evaluation and documentation of heat/mass transfer, mixing, and process safety at each scale transition.
- Lead P&ID reviews and communicate design intent/basis across disciplines, vendors, and partner functions.
- Develop and maintain drug substance API manufacturing processes/control strategies; translate development-scale chemistry into fit-for-purpose equipment specifications.
- Support preparation of IND/CTX sections and regulatory submissions/updates.
- Author and ensure timely completion of technical reports, basis-of-design documents, and engineering specifications.
- Plan/manage process engineering development activities; assign work, coordinate teams, and review progress.
- Ensure compliance with laws/regulations, SOPs, GMP, and safety procedures; lead/participate in Process Hazard Reviews/HAZOPs and hazard assessments.
- Train/mentor process engineers on equipment design, scale-up, GMP, and Foundry technical requirements.
Basic Qualifications:
- PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related; OR
- BS/MS in Chemical Engineering or related with 10+ yearsβ experience in pharmaceutical/biotech/CMO process engineering for drug substance API development/manufacturing.
Additional Skills/Preferences:
- Expertise in chemical engineering fundamentals and small molecule API unit operations (reaction chemistry, crystallization, extraction, distillation, etc.).
- Cross-functional project management experience.
- Leadership, collaboration, and strong communication skills (verbal/written to operations, management, regulators).
- Experience preferred: SMDD/equivalent R&D and manufacturing; cGMP process support in pilot/clinical environment; process simulation (DynoChem/Aspen) and controls systems (DeltaV).
- Ability to prioritize in fast-paced startup settings and manage ambiguity.
Other Information:
- Initial location: Parkwood West, Indianapolis, IN; permanent location: Lilly Medicine Foundry, Lebanon, IN.
- Limited travel (<10%).
- Ability to work in 24-hour manufacturing/lab environments.