Scientist / Sr. Scientist - QA Batch Disposition

Role Summary

Scientist / Sr. Scientist - QA Batch Disposition at Lilly. Responsible for final batch disposition of semi-finished and finished drug product batches for RTP commercial parenteral products, ensuring GMP compliance and timely release of high-quality medicines. Provides guidance on batch-related issues, leads quality matters in the Batch/Batch Disposition process, and supports quality systems and inspections.

Responsibilities

• Perform final batch disposition of semi-finished and/or finished drug product batches for RTP commercial parenteral products, ensuring GMP compliance and timely market release.
• Lead, mentor, and coach site personnel on quality matters related to the Batch/Batch Disposition process.
• Provide guidance to operational areas to maintain robust Quality Systems and GMP compliance.
• Review and approve GMP documents to ensure quality attributes are met (non-conformances, procedures, protocols, specifications, change controls).
• Participate in self-led inspections and support during internal/external regulatory inspections.
• Contribute to Six Sigma projects or process improvement initiatives to improve productivity in the Batch Disposition work center/site.

Qualifications

• Experience in quality assurance, batch disposition, and GMP compliance for parenteral products.
• Ability to review and approve GMP documents and support regulatory inspections.
• Strong leadership and mentoring capabilities within a quality-focused environment.
• Experience with process improvement initiatives (e.g., Six Sigma) is preferred.

Skills

• Quality systems and GMP knowledge
• Documentation review and approval
• Root cause analysis and non-conformance handling
• Process improvement and project participation
• Communication and cross-functional collaboration

Education

• Relevant science or engineering degree; advanced degree or professional certification in quality assurance or manufacturing could be preferred.

Additional Requirements

• Travel and physical demands are not specified as essential in the provided description.