Engineer - Drug Substance Synthetic Molecule Design and Development

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

Lilly’s Synthetic Molecule Design and Development (SMDD) organization develops synthetic active pharmaceutical ingredients from preclinical development through commercialization. The Engineer will support development and optimization of unit operations and processes for synthetic drug candidates, helping advance clinical trials, regulatory submissions, and commercialization. The role works on multidisciplinary teams with process chemists, analytical chemists, formulation scientists, and engineers.

The position focuses on engineering-led process development and scale-up, especially crystallization design and optimization for synthetic drug substances. The Engineer will define API physical properties needed for drug products and develop crystallization processes that meet physical-property and chemical-purity requirements. The work may use process analytical technology, continuous processing, mechanistic models, and novel formulation platforms to create robust, well-understood processes.

The role is based at Lilly Technology Center – North in Indianapolis, Indiana, with 0–10% travel. Lilly states an anticipated wage range of $67,500–$173,800. Full-time equivalent employees are eligible for a company bonus, and eligible employees may participate in a comprehensive benefits program.

Requirements

• B.S. or M.S. in chemical engineering or a closely related engineering field.
• Must be authorized to work in the United States on a full-time basis; Lilly will not support or sponsor work authorization or visas for this role.
• Strong technical skills in synthetic organic chemistry and experience as a hands-on technical contributor in a laboratory environment.
• Ability to apply chemical engineering fundamentals to crystallization process design, including heat and mass transfer, thermodynamics, crystallization and precipitation kinetics, solid–liquid separations, drying, particle-size reduction (milling), mixing theory, and experimental design.
• Experience with online and offline analytical techniques and PAT, such as image analysis tools, IR, Raman, and FBRM.
• Experience with solid-state characterization techniques such as XRPD, DSC, TGA, particle-size analysis, and microscopy.
• Demonstrated problem-solving skills.
• Strong verbal and written communication skills and ability to collaborate in a team environment.
• Ability to prioritize multiple activities and handle ambiguity.

Responsibilities

• Generate process-design and unit-operation knowledge using engineering principles for small molecules and other emerging therapeutic modalities.
• Ensure successful process scale-up through fundamental engineering principles and equipment knowledge.
• Design and execute laboratory experiments, including manual and automated high- and low-throughput reactor experiments, for crystallization process design and optimization.
• Develop drug-substance processes and manufacturing technologies, defining required API physical properties and designing crystallization processes to meet physical-property and chemical-purity requirements.
• Leverage and develop process analytical technology (PAT), continuous processing, mechanistic models, and novel formulation platforms to develop robust crystallization processes that enhance or tailor API physical properties.
• Apply engineering and business principles to design and characterize synthetic processes.
• Use numerical engineering modeling tools to characterize reaction kinetics, reaction mechanisms, and process separations.
• Develop creative solutions to improve existing processes and create new processes.
• Transfer process technical information to internal and external manufacturing sites.
• Provide technical oversight to external collaboration partners for laboratory and manufacturing activities.
• Author and maintain laboratory notebooks, technical reports, and other documentation.
• Design effective process and equipment flow strategies and select equipment appropriate for its intended use and process needs.
• Stay informed about new technology and best practices.
• Propose, justify, evaluate, and implement new equipment, processing techniques, and technologies.
• Use technology to improve safety, quality, and productivity in development and manufacturing.
• Publish and share original research through peer-reviewed articles and conferences.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level