Eli Lilly and Company · 1 week ago
Associate Director-Test-Methods/Systems-IDM
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Associate Director - Test Methods/Systems in IDM will oversee device testing methods, systems, and metrology while leading a team to ensure compliance and quality in device manufacturing.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
Demonstrated ability to lead teams and foster collaboration
Ability to work effectively 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 processes (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)
Preferred
Understanding of statistics and design of experiments
Experience with drug delivery systems and technologies (e.g., pre-filled and reusable devices)
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
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