Sr Director - Device Assembly and Packaging Operations

Role Summary

Sr Director - Device Assembly and Packaging Operations at Lilly. Lead DAP Operations and cross-functional leadership at the Lilly Kenosha site to ensure safety, quality, and operational excellence in device assembly and packaging.

Responsibilities

• Provide Health, Safety and Environmental (HSE) and Quality leadership for the DAP operational and flow team.
• Support site leadership to build a diverse and capable site organization focused on engineering principles and operational excellence; manage talent development and retention.
• Provide operational technical leadership and develop objectives to deliver safety, quality, and equipment/process effectiveness and efficiency aligned to the Business and Strategic Plan.
• Represent operational capabilities beyond the Kenosha site to other Lilly sites and global functional groups.
• Partner with Technical Services, Quality, Engineering and Tech@Lilly leadership to deliver operational results.
• Lead significant capital and technological projects with the team.
• Deliver equipment, lines, and supporting systems from user requirements through design, build, verification, qualification, validation, and operation.
• Develop local processes and procedures for the operational function; ensure practice matches procedure.
• Ensure alignment to meet production throughput goals, including daily manufacturing line operation, deviation/change management, variability reduction, and equipment/system reliability.
• Champion continuous improvement.
• Develop and maintain metrics to measure performance against objectives and implement improvements.
• Contribute to strategies in Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
• Interact with Regulatory Agencies during site inspections.
• Understand and influence the manufacturing control strategy for device assembly and packaging.

Qualifications

• Required: Bachelor's Degree in Engineering, Life Science, or Business/Operations.
• Required: At least 10 years of experience at a manufacturing site.
• Required: At least 5 years of previous management or leadership experience, including cross-functional collaboration.

Skills

• Cross-functional leadership and collaboration.
• Front-line experience in device assembly and/or packaging operations.
• Understanding of regulatory agency requirements.
• Facility or area startup experience; operations and engineering background.
• Experience with highly automated equipment and with combination products, device assembly, pharmaceutical packaging, drug product formulation, and aseptic filling.
• Equipment qualification and process validation experience; familiarity with Manufacturing Execution Systems and electronic batch release.
• Experience with ASRS warehouses or AGVs; deviation and change management systems including Trackwise.

Education

• Bachelor's Degree in Engineering, Life Science, or Business/Operations.

Additional Requirements

• Direct interaction with Regulatory Agencies during site inspections.