Principal Scientist - TS/MS Cleaning

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in 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.

Main Purpose and Objectives: 

The Cleaning Representative is responsible for managing the cleaning program for process equipment and ancillary components at the Lebanon manufacturing facility.  This position will interact with Engineering, Manufacturing, Quality Assurance, Quality Control, Validation, Development, and Regulatory departments.  Interaction may be required with other Lilly site/contract producers of Lilly products. 

This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.  The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule.

Key Responsibilities:

• Responsible for cleaning verification/validation activities supporting API manufacturing processes at the site.
• Work closely with technical leadership to actively manage cleaning development and cleaning verification/validation activities according to schedule.
• Author and maintain product-specific cleaning validation documents including: Cleaning Validation Master Plans (CVMP), Cleaning Flow Documents (CFD), and Cleaning Validation Protocols and Summary Reports
• Oversee execution of cleaning validation protocols and ensure alignment with approved strategies. Provide support to the process teams for cleaning activities ensuring all aspects of the flow are coordinated appropriately. Attend and lead (if required) process team meetings.
• Coordinate investigations related to cleaning. Trend events across equipment trains and products and drive improvements.
• Improve efficiency in cleaning processes and identify projects for improvement (e.g. activities that can run in parallel and those that need to run in sequence).
• Collaborate globally across Lilly sites to promote shared learning and continuous improvement in cleaning validation practices.
• Apply science- and risk-based approaches to enhance the robustness, efficiency, and compliance of cleaning processes.
• Develop and deliver training and educational materials on cleaning validation and related topics across Lilly manufacturing and packaging operations.
• Ensure cleaning validation activities are aligned with governing standards set by regulatory agencies and internal Lilly quality standards.

Minimum Requirements:

• Bachelor’s degree in Pharmacy, Science, Engineering or related field; advanced degree preferred.  
• Minimum of 5 years of experience in a cGMP large-scale pharmaceutical manufacturing facility. 
• Technical knowledge of cleaning equipment and cleaning regimes.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Practical experience with cGMPs and cleaning validation practices across multiple processes.
• Knowledge of relevant FDA and EU regulations relating to equipment cleaning in small molecule manufacturing.
• Experience directly supporting manufacturing operations is highly desirable.
• Ability to apply cleaning validation principles across drug substance and various other manufacturing technologies.
• Strong self-management and organizational skills. Strong analytical and problem-solving skills
• Proven ability to work independently and collaboratively within cross-funct