Director - Operations GMP Laboratories Lilly Medicine Foundry job opportunity at Eli Lilly and Company.

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DateMore Than 30 Days Ago bot
Eli Lilly and Company Director - Operations GMP Laboratories Lilly Medicine Foundry
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Pattern: full-time
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loacation US, Lebanon IN, United States Of America
loacation US, Lebanon IN....United States Of America

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. Lilly recently announced a   $4.5 billion   investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in   a single location , the Medicine Foundry will allow Lilly to further develop innovative solutions to   optimize   manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact .         In the Project Delivery Phase and Startup Phase of the project (2025 to 2028), roles will be fluid and dynamic as we   endeavor   to support the project delivery, build a new organization, develop and implement the necessary systems and business processes   required   to support GMP operations. This will require significant collaboration,   creativity   and resilience as the Lilly Medicine Foundry goes from design,   to start -up, and to steady-state operations .         Position Summary   The Director of Operations for Analytical GMP Laboratories will lead all aspects of GMP analytical operations at the Lilly Medicine Foundry. This role oversees startup, scale-up, and steady-state operations, ensuring laboratory capability, GMP compliance, and digital enablement. The position requires strategic leadership, operational excellence, and a strong quality culture to support manufacturing and regulatory commitments.     Key Responsibilities   Strategic Leadership & Operational Oversight   Lead QC laboratory operations, capability buildout, and   maintain   continuous   inspection   readiness.   Drive lab design, commissioning, workflow optimization, and implementation of 5S systems.   Own GMP compliance, quality systems, and data integrity standards across all analytical operations.   Team Development & Leadership   Build and develop high-performing   teams;   lead hiring, onboarding, training, mentorship, and performance management.   Foster a culture of safety, quality, and continuous improvement.   Equipment & Technology Management   Oversee instrumentation   selection , URS development, and full lifecycle management (IQ/OQ/PQ, PM, calibration, troubleshooting, decommissioning).   Ensure compliance with CQV/CSV and change control processes.   Operational Excellence   Manage capacity planning, scheduling, and laboratory inventories.   Oversee sample intake, chain of custody, and   timely   result release.   Ensure robust   deviation   management, investigations, and CAPA implementation.   Safety & Compliance   Establish and   maintain   a strong safety and quality culture; lead HSE initiatives and hazard mitigation.   Ensure compliance with regulatory requirements, SOPs, GDP, and method standards.   Cross-Functional Collaboration   Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy.     Minimum Qualifications Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline.   Ph.D. with 5+ or BS/MS with   1 0 + years of experience in GMP analytical laboratories with progressive leadership roles.   Extensive experience with CQV/CSV, quality systems, and regulatory compliance.   Strong strategic thinking, influence, and stakeholder management skills.   Proficiency   in digital QC systems (LIMS, QMS, Empower, SAP, ELN) and continuous improvement methodologies.     Additional Skills and Preferences:     Experience with product development, including technical transfer of analytical methods into manufacturing operations.    Demonstrated ability to drive and accept change.  Good interpersonal skills and a sustained tendency for collaboration.    Demonstrated success in persuasion, influence, and negotiation.    Ability to prioritize multiple activities and manage ambiguity.    Other Information:    Initial location at Lilly Technology Center, Indianapolis .       Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana .       Flexibility to work from Indianapolis (or other Lilly sites) may be   required   throughout 2026 and 2027.    Position requires   on -site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.    0-10% travel   required .     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 $148,500 - $257,400 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. #WeAreLilly

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