Sr. Principal Scientist - QA

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

** 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:

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* The Sr. Principal Scientist - QA, is responsible for assuring and verifying QA responsibilities and expectations support for radioligand drug product manufacturing. The role provides Quality oversight during aseptic drug product manufacturing activities and performs final quality disposition of drug products for the Indianapolis Radioligand Therapies (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.

+ 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 in collaboration with the site…