Sr. Principal Scientist - QA

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.

Responsibilities

Support site safety efforts for the QA Ops team; Provide quality support of IRLT with real-time review of batch records on the floor, coverage during media fill, and first line support for quality escalations; Ensure in-process checks are completed for batch disposition, including deviations, changes and batch documentation; Complete disposition of drug product batches and drug substance intermediates; Ensure regular presence in operational areas as part of QA on the Floor support and record GMP compliance and inspection readiness observations; Plan and schedule qualification and requalification activities; Provide training to floor QA and batch QA personnel as SME and qualified trainer; Provide technical/quality review of manufacturing-supporting documentation; Support development of the site operational readiness plan, quality processes and operational procedures; Drive operational excellence through data analysis to reduce variability and cycle times; Work cross-functionally on metrics reviews and issue/deviation management; Assess and triage deviations with the site process team; Lead, mentor and coach operations and support personnel as quality SME during troubleshooting

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; On-site role (Indianapolis Radioligand Therapies); Authorized to work in the United States on a full-time basis; Lilly will not provide support for or sponsor work authorization or visas for this role

Nice to have

Ability to work independently and bring cross-functional team members together; Strong knowledge of Quality Management Systems and applicable regulatory requirements; Previous regulatory inspection readiness and inspection execution experience; Previous experience with Manufacturing Execution Systems and electronic batch release; Excellent interpersonal, written and oral communication skills; Previous experience working with radioligands preferred

Benefits

Company bonus for full-time equivalent employees (depending on company and individual performance); Company-sponsored 401(k); Pension; Vacation benefits; Medical, dental, vision and prescription drug benefits; Flexible benefits (healthcare and/or dependent day care flexible spending accounts); Life insurance and death benefits; Time off and leave of absence benefits; Well-being benefits (employee assistance program, fitness benefits, employee clubs and activities)