Associate Director-Test-Methods/Systems-IDM

Role Summary

Associate Director-Test-Methods/Systems-IDM

Responsibilities

• Lead the Indianapolis Device Manufacturing organization‚Äôs activities and personnel for device, cartridge, and syringe test methods, test systems, and metrology.
• Develop, recruit, and retain technical personnel to support current and future analytical methods and metrology for delivery devices and primary containers.
• Establish and maintain standards for developing, validating, and transferring device analytical methods and test systems.
• Ensure qualified state of test systems supporting device and cartridge analytical methods.
• Provide oversight for registered lot release methods and in-process testing of devices, containers, and components.
• Support business needs through long-range and annual planning processes.
• Execute all tasks while meeting Safety and Quality objectives.
• Communicate status and manage change via regular updates to management teams, CMC project management, and site leadership.
• Deliver customer service for manufacturing sites regarding testing needs (investigations, continuous improvement, technical support).
• Participate and lead governance processes (change management boards, quality lead teams).
• Set laboratory priorities for TS/MS, including direction and resourcing for engineering studies and design of experiments.
• Manage Human Resources for all direct reports.

Qualifications

• Strong leadership and supervisory experience.
• Ability to work across boundaries (equipment suppliers, Lilly manufacturing sites, parts suppliers, development teams).
• Mechanical aptitude (knowledge of mechanical equipment, controls, and validation for medical devices).
• Knowledge of manufacturing (preferably discrete manufacturing).
• Understanding of GMP and ISO requirements for drug delivery devices.
• Familiarity with analytical test systems and test method requirements for drug delivery devices.
• Additional Preferences: Understanding of statistics and design of experiments; Experience with drug delivery systems and technologies (e.g., pre-filled and reusable devices).
• Education Requirements: BS or MS in Engineering (preferably Mechanical Engineering).
• Other Information: This role supports global device design and manufacturing; Requires some domestic and international travel.