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., DynoChem, 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 & ID reviews 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.
Basic Qualifications
- 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.
Additional Skills and Preferences
- 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 skills and collaboration with internal and external partners.
- Success in persuasion, influence, and negotiation with stakeholders at all levels.
- Excellent verbal and written communication skills.
- Broad 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.
- Technical proficiency and ability to translate scientific information into actionable plans, resource strategies, and project budgets.
- Experience with process simulation tools (e.g., DynoChem, Aspen) and control systems (e.g., DeltaV) preferred.
Other Information
- Initial location: Parkwood West, Indianapolis, IN.
- Permanent location: Lilly Medicine Foundry, Lebanon, IN.
- Limited domestic and international travel (<10%) may be required.
- Role requires ability to work in 24‑hour manufacturing and laboratory environments.
- Role classified at the R5 (Advisor) level within Lilly's Engineering job family.
EEO Statement
Lilly is an equal‑employment opportunity employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, veteran status, disability, or any other legally protected status. Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, providing equal opportunities. If you require accommodation, please complete the accommodation request form for further assistance.
Benefits & Compensation
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 employees will also be eligible for a company bonus depending on performance. Lilly offers a comprehensive benefit program including 401(k) participation, pension, vacation, medical/dental/vision and prescription drug benefits, flexible benefits, life insurance, death benefits, time‑off and leave of absence benefits, and well‑being benefits such as employee assistance program, fitness benefits, and employee clubs.