Advisor - Raw Materials Testing GMP Laboratories Lilly Medicine Foundry

Lilly•Lebanon, IN

2d•Onsite

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. 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 (2026 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 Advisor/Sr Advisor Raw Material Testing, provides strategic and operational leadership for the raw material testing function within Analytical GMP Laboratories. This role ensures timely, compliant, and scientifically sound testing of incoming raw materials that support manufacturing operations. The leader is responsible for enabling high quality analytical performance, driving continuous improvement, ensuring inspection readiness, and fostering cross functional collaboration to meet site and global quality objectives.

Requirements

Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline.
Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles.
Extensive experience in raw material sampling, testing and release strategies
Proficiency in analytical techniques such as chromatography and spectroscopy.
Experience with LIMS, SAP, and quality systems including TrackWise and Veeva.

Nice To Haves

Experience with Lean/Six Sigma methodologies and continuous improvement approaches.
Strong communication, stakeholder engagement, and cross functional leadership capabilities.
Familiarity with global regulatory requirements and industry audit expectations.
Demonstrated ability to drive and accept change. Demonstrated success in persuasion, influence, and negotiation.
Ability to prioritize multiple activities and manage ambiguity.

Responsibilities

Set the vision and direction for the Raw Material Testing function, ensuring alignment with site and global quality strategies.
Develop and execute strategies for capacity planning, resource optimization, and adoption of analytical technologies that enhance efficiency, compliance, and scientific rigor.
Ensure full adherence to cGMP, global quality standards, and applicable regulatory requirements across all raw material testing activities.
Maintain a state of continuous inspection readiness; lead internal and external audits and represent the function during regulatory inspections.
Oversee deviation investigations, CAPA implementation, and uphold data integrity principles (ALCOA+).
Lead end-to-end raw material testing processes, including sampling, scheduling, execution, data review, and timely release of materials.
Oversee equipment lifecycle management, including installation, qualification, calibration, and preventive maintenance.
Ensure robust documentation practices and support continuous improvement initiatives to optimize laboratory operations.
Serve as the primary liaison between QC, QA, warehouse, and manufacturing to ensure seamless flow of raw material testing and release activities.
Participate in site leadership forums and global network discussions, contributing to best practice sharing and harmonization efforts across the enterprise on material release strategies.
Contribute to planning for analytical capabilities, capacity expansion, technology upgrades, and infrastructure investments.
Lead and develop a team of analysts and scientists, including staffing, training, qualification, coaching, and performance management.
Foster a culture centered on safety, quality, scientific excellence, and continuous learning.

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).

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