Senior/Principal Scientist - Quality Operations

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:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Description:

The Scientist -Quality Operations, is responsible for assuring and verifying QA responsibilities and expectations support for radioligand drug product manufacturing. The role provides Quality oversight as shift lead during aseptic drug product manufacturing activities and performs final quality disposition of drug products for the IRLT production site. 

Key Objectives/Deliverables:

• Support the site to ensure a safe work environment including supporting safety efforts for the QA Ops team.

• Provide quality support of IRLT with a focus on holistic involvement in key activities including real time review of batch records on the floor, coverage during media fill, providing first line of support for quality escalations associated with or impacting the manufacturing processes and Quality Control operations.

• Ensure that documented in-process checks have been completed for batch disposition including but not limited to deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.

• Complete disposition of Drug product batches and Drug substance Intermediates.

• Ensure regular presence in operational areas (preparation, formulation, synthesis, filling and visual inspection, AQL, QC, warehouse etc. areas) as a part of QA on the Floor support to ensure facility is compliant with GMP and inspection ready. Record compliance and inspection readiness observations per established local and global procedures.

• Present QA floor observations quarterly driving cross‑functional visibility into trends, corrective actions, and opportunities for process optimization.

• Plan and schedule tasks qualification and requalification activities. Provide training to floor QA and batch QA personnel as SME and qualified trainer for batch and floor QA tasks qualifications. Oversee execution of the same activities after training completion to provide feedback for sustaining compliance and development of the QA Ops organization.

• Provide technical/quality review of documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols, training documents, analytical method validations), as applicable.

• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures.

• Drive operational excellence in floor operations and disposition process through data analysis to reduce variability and shift performance cycle times to align with supply delivery targets.

• Work cross-functionally with the area process teams for metrics reviews (e.g. deviation closure times, batch record release times, training completion etc.) to enhance operational support, and issue / deviation management.

• Assess and triage deviations that occur on shift in collaboration with the site process team.

• Lead, mentor, and coach operations and support personnel as quality SME during troubleshooting activities for manufacturing and QC operations.

• Perform any additional duties as required to support the business.

Minimum Requirements:

• Bachelor's degree in science, engineering, computer, pharmaceutical related field of study or related technical degree.

• 5+ years of experience in QA/QC roles in the pharmaceutical industry.

• Mandatory Ability to work Wednesday - Saturday 10:00 am to 8:30 pm (Indianapolis, RLT Manufacturing Site (Onsite).

• Qualified applicants must be authorized to work in the United