Advisor – Process Engineer. Lilly Medicine Foundry
Pharma
Job description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location , the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Lilly Medicine Foundry Process Engineering organization is responsible for the chemistry, formulation, analytical, and engineering efforts to support development and scale-up of investigational small molecules to support clinical and toxicology studies through late-stage clinical trials. The Advisor – Process Engineer will serve as a senior technical authority within this organization, 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 is a unique opportunity to be part of the startup team for a greenfield manufacturing site and to shape the processes, equipment, and engineering culture that will enable a successful transition to GMP manufacturing operations. 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 departmen
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