Senior/Principal Scientist - Quality Control Project Manager

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 a cutting-edge facility for the manufacture of new modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, and start up the facility for both clinical and commercial supply. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Description:

In addition to new modalities manufacturing, this facility will also provide oversight of external manufacturing of new modalities. The Scientist – Quality Control Project Management – Advanced Therapies is a technical role in the Quality Control Laboratory helping to ensure the manufacture of products to predetermined standards to meet both Lilly and external requirements by focusing on managing the testing of products manufactured and/or tested at locations external to Lilly. This role is responsible for the planning, coordination, and execution of laboratory testing of all methods of products managed by the Lilly Lebanon Advanced Therapies Manufacturing (LP2) team. The successful candidate will work in partnership with internal LP2 personnel for technical support, with the Lilly global Analytical Sciences and Quality Control Organization (AQCO), External Manufacturing teams (API-EM and DP-EM), as well as third-party contract manufacturing and testing partners to ensure that products are tested and controlled as needed to achieve successful product production.

Key Objectives/Deliverables:

• Serve as a liaison between contract manufacturers and Lilly to perform coordination, review, and interpretation of quality control product testing data and serve as the initial point of contact for all quality control-related issues.

• Provide analytical support, project leadership, and/or technical direction for testing performed internally to LP2 or by third-party contract partners.

• Oversee and participate in the transfer of analytical methods, including setting strategic direction, authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations.

• Leverage organizational understanding to identify correct SMEs to utilize their technical skills to lead or perform in-depth investigations into out of spec results and aberrant data.

• Track project progress and performance, including maintenance of transparent and accessible project documentation (timelines, budgets, status), ensuring all team members and partners have access to up-to-date project information.

• Define project scope, objectives, and deliverables in collaboration with partners; develop detailed project plans including timelines, milestones, and resource allocation; identify project requirements and ensure alignment with organizational goals.

• Provide technical oversight for Periodic Management Reviews. Leads resolution of technical issues including those related to control strategy and manufacturing.

• Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.

• Interact effectively with business partners and auditors to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.

• Network with groups internal and external to Lilly to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met.

• Help define and execute inspection readiness activities for manufactured products.

• Employ excellent communication skills to manage internal and external relationships