Associate Director-Test-Methods/Systems-IDM

Eli Lilly and Company • Indianapolis, IN

28d

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. Position Brand Description: 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 (with equipment suppliers, Lilly Mfg. sites, parts suppliers, development teams, etc.)
• Mechanical aptitude (ideally knowledge of mechanical equipment, controls, and validation for medical devices)
• Knowledge of manufacturing (ideally discreet manufacturing)
• Understanding of GMP and ISO requirements relative to drug delivery devices
• Understanding analytical test system 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 in drug delivery systems and technologies (e.g., pre-filled and re-usable devices)

Responsibilities

• Develop, recruit and retain technical personnel to support the current and anticipated analytical methods and metrology for the portfolio of current and future delivery devices and primary containers that are integrated with devices.
• Develop and maintain the standards by which device analytical methods and test systems are developed, validated, and transferred to sites.
• Develop and maintain the qualified state of test systems used in support of device and cartridge analytical methods.
• Provide method and analytical test system oversight for the registered lot release methods as well as in-process testing of devices, containers and components.
• Provide business needs through the business planning process (long-range and yearly plans).
• Execution of all tasks while meeting Safety and Quality objectives of the organization.
• Communication of status and management of change for all activities via regular updates to the management teams (development and manufacturing), CMC project management, and manufacturing sites leadership groups.
• Customer service for manufacturing sites of primary container, drug delivery devices, and their components for testing needs such as investigations, continuous improvement activities, technical support, etc.
• Participation and leadership in governance processes – change management boards, and quality lead teams.
• Lead laboratory priorities for TS/MS by providing direction and resourcing for engineering studies, design of experiments, etc.
• Human Resources Management 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