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 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.
Basic 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.
Additional Skills and Preferences- Deep technical expertise in chemical engineering fundamentals and pharmaceutical process development, including reaction chemistry, crystallization, extraction, distillation, and other unit operations relevant to small molecule API manufacturing.
- Strong knowledge of and experience in project management in a cross-functional pharmaceutical development environment.
- Demonstrated leadership capabilities, especially in team environments with diverse scientific and engineering disciplines.
- Good interpersonal skills and demonstrated collaborative abilities with internal and external partners.
- Demonstrated success in persuasion, influence, and negotiation with stakeholders at all levels of the organization.
- Excellent verbal and written communication skills, with the ability to convey complex technical information to diverse audiences including operations staff, management, and regulatory agencies.
- Breadth of previous SMDD or equivalent pharmaceutical R&D and manufacturing experience preferred.
- Preferred experience with cGMP manufacturing and process support in a pilot plant or clinical manufacturing environment.
- Ability to prioritize multiple activities simultaneously and manage ambiguity in a fast-paced startup environment.
- Ability to influence others and promote a positive, high-performance work environment.
- Demonstrated initiative and risk-taking in tackling novel technical challenges.
- Demonstrated technical proficiency and ability to translate technical and scientific information into actionable plans, resource strategies, and project budgets.
- Experience with process simulation tools (e.g., DynoChem, Aspen) and process control systems (e.g., DeltaV) preferred.
Other Information - Initial location at Parkwood West, Indianapolis, IN.
- Permanent location at the Lilly Medicine Foundry, Lebanon, Indiana.
- Limited domestic and international travel (< 10%) may be required.
- Role requires the ability to work in 24-hour manufacturing and laboratory environments.
- Role is classified at the R5 (Advisor) level within Lilly's Engineering job family.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$129,000 - $189,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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