Associate Director-Test-Methods/Systems-IDM

Eli Lilly and Company • Us, IN

2d

About The Position

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. Lead the Indianapolis Device Manufacturing organization’s activities and personnel for device, cartridge, and syringe test methods, test systems, and metrology.

Requirements

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

Nice To Haves

• Understanding of statistics and design of experiments.
• Experience with drug delivery systems and technologies (e.g., pre-filled and reusable devices).

Responsibilities

• 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.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees