Senior Process Engineer – Biologics- Lilly Medicine Foundry

About the Lilly Medicine Foundry

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.

Organizational Overview

Lilly is currently constructing an advanced research facility for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

We are seeking a Senior Process Engineer to support the facility in Lebanon with a focus on biologics drug substance manufacturing, including upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations. This position involves solving technical challenges with equipment design, developing and sustaining process knowledge, optimizing processes, and managing equipment capabilities.

Responsibilities

The Senior Process Engineer provides technical assessment and support for production operations in the areas of developing and sustaining process knowledge, process and equipment support, process optimization, equipment capability and asset management, and engineering business systems. This role is to serve as a process engineer supporting large molecule biologics drug substance active pharmaceutical ingredient (API) manufacturing.

• Perform impact and risk assessments for unit operations
• Learn the lab and plant design for the reactors including automation recipes and procedures
• Ensure that people and their environment are safe and that company policies concerning safety are followed
• Ensure processing equipment remains compliant with internal Quality System requirements, applicable engineering standards, and cGMP requirements
• Active engagement and communication with: HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing
• Author, review, or approve high-quality technical reports as required to explain basis of design, including facility fit assessments, process characterization, and comparability considerations
• Support scale-up/scale-down strategy and troubleshooting for biologics unit operations, incorporating cell culture media/feed strategies, chemical engineering first principles, viral clearance requirements, and contamination control strategies as applicable
• Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately
• Develop or review plans and timetables for project work
• Support and suggest process and equipment improvements and technology advancements to ensure innovative and robust processes are developed

Basic Requirements

• BS or MS in chemical engineering, biochemical engineering, or a related discipline
• Minimum of 2 years of experience with a pharmaceutical, biotech, or CMO environment supporting the process engineering of biologics drug substance manufacturing or development
• Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, media prep, centrifugation, chromatography or filtration)
• Qualified applicants must be authorized to work in the United States on a full-time basis

Additional Preferences

• Deep technical interest and understanding in the field of biologics/bioprocess engineering
• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability
• Experience with single-use technology systems and associated engineering considerations
• Experience with any of the following software packages: DeltaV, bioreactor SCADA/process chromatography control systems, Dynochem, Aspen, and/or electronic lab notebooks
• Familiarity with biologics regulatory submissions (IND, BLA, CTD modules) and process characterization/validation requirements
• Strong analytical and problem-solving skills
• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management
• Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals
• Understanding of process control systems relevant to biologics unit operations
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented
• Guidance/mentoring of others through processes
• Flexibility to meet business needs

Other Information

Initial location at Parkwood West, Indianapolis, IN. Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.