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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.

Key Objectives / Deliverables

+ 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.

Minimum 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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $180,400

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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