Senior​/Principal Scientist - Quality Control Project Manager

Senior/Principal Scientist - Quality Control Project Manager

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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 across 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 put people first and look for people who are determined to make life better for people around the world.

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. It will include next‑generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance.

This is a unique opportunity to be part of the team that starts up the greenfield manufacturing site, and the successful candidate will help design, commission, and start up the facility for both clinical and commercial supply.

The Quality Control Laboratory ensures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

This role is in the Quality Control Laboratory and focuses on managing the testing of products manufactured and/or tested at locations external to Lilly. The Scientist – Quality Control Project Management – Advanced Therapies is a technical role that helps ensure products are tested and controlled to meet both Lilly and external requirements. The responsibilities include planning, coordination, and execution of laboratory testing of all methods for products managed by the Lilly Lebanon Advanced Therapies Manufacturing (LP2) team.

The successful candidate will partner with internal LP2 personnel, Lilly Global Analytical Sciences and Quality Control Organization (AQCO), External Manufacturing teams, as well as third‑party contract manufacturing and testing partners to ensure products are tested and controlled as needed for successful production.

• 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) so that all team members and partners have 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. Lead resolution of technical issues including those related to control strategy and manufacturing.
• Help develop a strong quality culture by 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…