Sr. Principal Scientist – CT Parenteral Ops

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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

This position is within the Operations (OPS) team of the manufacturing organization. The Scientist will provide technical oversight and ownership for assigned processes which could include, dispensing and formulation, filling, freeze drying, inspection and/or final packing into shippable containers.  The Scientist will also represent, and be the primary owner, of new product technology transfers to B358 CT operations while supporting day-to-day manufacturing operations. 

The scientist will effectively collaborate with both internal and external partners to achieve desired results. 

Key Objectives/Deliverables:  

• Knowledgeable on how to apply GMPs in a clinical trial environment 

• Capability to write, train, review, and follow procedures applicable to the CT business 

• Responsible for issuance of pre-executed B358 CT manufacturing batch records and performing post-execution technical review 

• Utilize change management system to create, approve, execute, close changes and associated action items relevant the CT manufacturing process 

• Ownership of ancillary support processes (Filter Integrity Testing, etc) 

• Author and review GMP manufacturing related investigations and complaint investigations 

• Author, review, and execute nonroutine technical studies to support manufacturing 

• Ownership of Process Risk Assessments 

• Maintain ownership and emphasis on quality, ensuring quality in all daily activities 

• Responsible for maintaining the B358 approved GMP consumables list and performing activities for adding new consumables 

• Responsible for performing SME review of vendor changes 

• Support process engineers with manufacturing technical oversight 

• Participate in new equipment PQ/startup activities through Reviews, Approvals, Execution and/or consultation on activities as needed 

Basic Requirements: 

• 5+ years experience in Formulation Development, CT or Commercial manufacturing. 

• Exceptional organizational skills with attention to detail 

• Strong problem-solving skills with the ability to identify key issues in manufacturing process and lead a team to the appropriate solution(s) for complex problems 

• Excellent verbal and written communications skills with the ability to interact well in a team environment and across multiple levels of an organization