Sr. Director - Device Assembly and Packaging 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.

The Device Assembly and Packaging (DAP) Operations Sr Director is responsible to provide leadership to DAP Operations and cross functional leadership to the DAP Flow Team for the Lilly Kenosha site. The Operations Director will deliver the operational organization and readiness agenda in alignment with the business and strategic plan. The Senior Director – DAP is a key member of Kenosha Site Lead Team ensuring safety, quality, and operational excellence.

Key Objectives/Deliverables

• 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 based in engineering first principles and operational excellence.  Talent management, development, and retention within the Kenosha organization (and beyond).

• Provide operational technical leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency. 

• Represent operational capabilities beyond the Lilly Kenosha site (e.g. other Lilly sites and global functional groups). 

• Partner with Technical Services, Quality, Engineering and Tech@Lilly leadership to deliver operational results.

• Actively engage team and deliver significant capital and technological projects.

• Deliver equipment, lines, and supporting systems through user requirements, design, build, verification, qualification, validation, and subsequent operation. 

• Develop local processes and procedures for the operational function.

• Ensure practice matches procedure.

• Ensure the functions are aligned and driven to meet production throughput goals including daily operation of the manufacturing lines, deviation and change management, variability reduction, and equipment/system reliability.

• Champion continuous improvement.

• Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.

• Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).

• This role has direct interaction with Regulatory Agencies during site inspections.

• Understand and influence the manufacturing control strategy for device assembly, and packaging.

Basic Qualifications

• Bachelor's Degree in Engineering.

• At least 10 years of experience at a manufacturing site

• At least 5 years previous management or leadership experience including leading or working effectively with a cross-functional group.

Additional Skills/Preferences

• Including leading or working effectively with a cross functional group

• Front line experience in device assembly and or packaging operations

• Solid understanding of basic requirements of regulatory agencies

• Previous facility or area start up experience

• Previous experience in operations and engineering

• Previous experience with highly automated equipment

• Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment

• Previous equipment qualification and process validation experience

• Previous experience with Manufacturing Execution