Eli Lilly and Company · 1 month ago
Associate Director-Test-Methods/Systems-IDM
US, Indianapolis IN
Full-time
Onsite
Lead/Staff, Director/Executive
$123K/yr - $180K/yrEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving the lives of people around the world. The Associate Director will lead the Indianapolis Device Manufacturing organization’s activities and personnel for device, cartridge, and syringe test methods, ensuring compliance with safety and quality objectives while managing technical personnel and overseeing analytical methods and test systems.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Education Requirements: BS or MS in engineering, preferably mechanical engineering
Preferred
Understanding of statistics and design of experiments
Experience in drug delivery systems and technologies (e.g., pre-filled and re-usable devices)
Benefits
Company bonus
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.
Founded in 1876
10001+ employees
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
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
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