Project Manager - Test Methods

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.

The Project Manager - Test Methods in IDM (Indianapolis Device Manufacturing) Test Methods and Metrology provides oversight for device* test method and test system coordination across all impacted Lilly sites and contract manufacturers, device test method business processes, and device test method business process training. This position supports the global device manufacturing network and leads and supports technical, compliance, and/or compendial initiatives for the device and container technical agendas, including test system qualification and implementation. This position partners with peers, device/cartridge manufacturing sites and various functions (e.g. Regulatory) to ensure consistency and rigor of device testing initiatives.

*Device Test Methods is a general term encompassing any methods owned by the IDM Test Methods and Metrology group and includes methods for cartridges, syringes auto-injectors, among standard needle injection systems and drug delivery devices.

Key Objectives/ Deliverables:

Device Test Method Coordinator:

• Manages and coordinates activities to ensure consistent test systems and device Test Methods are used across all impacted Lilly sites (including the IDM QC Lab) and Contract Manufacturers.

Test Method Business Process:

• Provides stewardship for device test method business processes.
• Effectively partners with device / cartridge / syringe networks to ensure alignment of device test method management systems.
• Supports global activities as required.

Device and Container Technical Agenda:

• Supports the assessment, development, and implementation of critical test system and test method projects in support of device and primary container initiatives.
• Manages change controls and projects to meet project deliverable timelines.
• Provides process and business support to the continuous improvement and life-cycle management of Test Methods and relevant test systems.

Partnership:

• Actively partners and collaborates with peers, customers and various functions to ensure consistency and rigor as well as improve operational excellence of global and local device test method business processes.

Minimum Requirements:

• Bachelor's Degree in STEM
• 2+ year of project management experience and ability to drive and influence cross-functional projects across a global network.
• 2+ year of manufacturing experience

Additional Preferences:

• Strong business problem-solving and trouble-shooting skills, driving to resolution with the proper sense of urgency and accountability.
• Strong technical, leadership and influencing skills.
• Strong self-management and self-motivational skills.
• Excellent oral and written communication skills.
• Strong interpersonal / teamwork skills.
• Flexibility to work in teams or individually as necessary.
• Experience in Device Manufacturing
• PMP Certification
• Six Sigma Green Belt or Black Belt Certification
• Experienced with analytical test systems and Test Methods and related processes (qualification, validation, transfer).
• Strong understanding of test system and test method requirements in a GMP environment.
• Strong understanding of the Quality System and ability to successfully adapt projects to meet requirements.

Additional Information:

• This role primarily supports local manufacturing but could require some domestic and international travel (< 10%)

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