Advisor Projects & Strategy Analytical GMP Laboratories Lilly Medicine Foundry

Lilly•Lebanon, IN

1d•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 of Project & Strategy for Analytical GMP Laboratories will lead clinical manufacturing and analytical strategy for GMP testing laboratories at the Lilly Medicine Foundry. This role drives phase-appropriate, risk-based analytical strategies from development through GMP execution, oversees strategic planning across CMC analytical deliverables, and partners cross-functionally to align analytical strategy with compliance, capability build, and digital enablement.

Requirements

MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
10+ years of experience in analytical development, GMP laboratories, or CMC functions.
Strong understanding of ICH guidance, GMP principles, lifecycle management, and regulatory frameworks.

Nice To Haves

Proven cross-functional leadership experience.
Experience across synthetic and biological modalities.
Familiarity with PAT, automation, and high-throughput workflows.
Continuous improvement mindset with demonstrated CI experience.
Strong strategic thinking, influence, and stakeholder management skills.

Responsibilities

Strategic Leadership & Analytical Planning
Define and lead phase-appropriate, risk-based analytical strategies to support clinical manufacturing.
Develop integrated method readiness strategies, including validation and transfer across multiple modalities.
Oversee CMC analytical activities, specifications, stability strategies, and lifecycle elements.
Digital Enablement & Technology Advancement
Support digitalization initiatives and implementation of new technologies to enhance analytical workflows.
Drive adoption of PAT, automation, and high-throughput approaches for efficiency and compliance.
Continuous Improvement & Lifecycle Management
Champion continuous improvement initiatives and analytical lifecycle performance metrics.
Ensure alignment with GMP, ICH guidance, and regulatory frameworks throughout the product lifecycle.
Cross-Functional Collaboration
Partner with QA, QC, Manufacturing, Engineering, and R&D to ensure analytical strategies support clinical and commercial objectives.
Act as a key liaison for technology transfer and method strategy across Foundry operations.

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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