Associate Director-Test-Methods/Systems-IDM

Role Summary

As the Associate Director - Test Methods/Systems in IDM you will oversee and coordinate the Indianapolis Device Manufacturing organization’s activities and team members for device, cartridge, and syringe test methods, test systems, and metrology.

Responsibilities

• Recruit, develop, and retain technical talent 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 test systems supporting device and cartridge analytical methods remain qualified and compliant.
• 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 progress and manage change through regular updates to management teams, CMC project management, and site leadership.
• Deliver responsive support for manufacturing sites regarding testing needs (investigations, continuous improvement, technical assistance).
• Participate in and guide governance processes (change management boards, quality leadership teams).
• Collaborate with teams to set laboratory priorities for TS/MS, including direction and resourcing for engineering studies and design of experiments.
• Provide coaching and development for team members and ensure effective resource management.

Qualifications

• Required: Demonstrated ability to lead teams and foster collaboration.
• Required: Ability to work effectively across boundaries (equipment suppliers, Lilly manufacturing sites, parts suppliers, development teams).
• Required: Mechanical aptitude (knowledge of mechanical equipment, controls, and validation for medical devices).
• Required: Knowledge of manufacturing processes (preferably discrete manufacturing).
• Required: Understanding of GMP and ISO requirements for drug delivery devices.
• Required: Familiarity with analytical test systems and test method requirements for drug delivery devices.
• Preferred: Understanding of statistics and design of experiments.
• Preferred: Experience with drug delivery systems and technologies (e.g., pre-filled and reusable devices).

Education

• Required: BS or MS in Engineering (preferably Mechanical Engineering).

Additional Requirements

• This role supports global device design and manufacturing.
• Requires some domestic and international travel.