Engineer/Sr. Engineer/Principle Engineer – Drug Product, Synthetic Molecule Design and Development (SMDD)

Role Summary

Engineer/Sr. Engineer/Principle Engineer – Drug Product, Synthetic Molecule Design and Development (SMDD) is responsible for designing and optimizing drug product processes from lab through manufacturing scales, collaborating with chemists, analytical chemists, engineers, formulation scientists, and modelers. The role focuses on developing technical solutions to accelerate portfolio development and overseeing scale-up and technology transfer to manufacturing facilities, with duties based in Indianapolis, IN.

Responsibilities

• Apply engineering fundamentals towards designing and optimizing continuous and batch drug product processes at lab, pilot, and manufacturing scales, including but not limited to powder feeding, powder mixing, wet and dry granulation techniques, encapsulation, tablet compaction, spray dry dispersion, hot melt extrusion, and tablet film coating, to ensure successful scale-up of processes through fundamental engineering principles and equipment knowledge.
• Design and execute experiments in a laboratory/pilot plant setting and/or leverage scale-up and process control models to ensure robust processes capable of meeting early and late phase demands by planning and managing both short-term and long-term development activities.
• Develop and review work plans and timelines for project work, recommending resource allocation to accomplish the projects, provide updates, and communicate progress/needs.
• Help to develop stage-appropriate process control strategies encompassing necessary aspects such as equipment operations, automation systems, PAT, model-based predictions, and methods of data reconciliation and monitoring in real time.
• Engineers in SMDD will be responsible for overseeing scaleup and technology transfer to manufacturing facilities within and external to Lilly through team meetings, site visits, and process monitoring.
• Author and maintain documentation such as laboratory notebooks, technical reports, and regulatory submissions dealing with the work performed by the department, including preparation or oversight and review of the appropriate manufacturing and controls portion of regulatory submissions.
• Stay informed about new technology and best practices. Propose, justify, evaluate, and implement new equipment, processing techniques, and technologies.
• Utilize technology to improve safety, quality, and productivity, both in development and manufacturing.
• Foster an inclusive environment by promoting diverse thought and shared experience to deliver innovative solutions that address unmet technical needs.
• Publish and share original research externally through peer-reviewed articles and conferences.

Qualifications

• Required: B.S. in chemical engineering or closely related field with 0–12 years of industry experience, or M.S. with 0–9 years of industry experience.
• Preferred: Strong technical skills in drug product development with hands-on experience in a laboratory/pilot plant environment within pharmaceuticals; demonstrated problem-solving skills, attention to detail, and result-oriented behavior; strong verbal and written communication skills and ability to collaborate in a team; ability to prioritize multiple activities and handle ambiguity.

Education

• B.S. (0–12 years industry experience) or M.S. (0–9 years industry experience) in chemical engineering or closely related field.

Additional Information

• Travel: 0 to 10%.
• Location: Indianapolis, IN; Lilly Technology Center – North (LTC-N).