Advisor Projects & Strategy Analytical GMP Laboratories Lilly Medicine Foun at Lilly

Lebanon, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

0.0

Posted On

16 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Strategic Leadership, Analytical Planning, Method Validation, Method Transfer, CMC Analytical Deliverables, Digitalization Initiatives, Process Analytical Technology (PAT), Automation, High-Throughput Approaches, Continuous Improvement, Lifecycle Management, Cross-Functional Collaboration, Technology Transfer, Risk-Based Analytical Strategies, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

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. Key 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. Minimum Qualifications 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. Additional Skills and Preferences 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. 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 $126,000 - $204,600 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 At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Responsibilities

This role leads clinical manufacturing and analytical strategy for GMP testing laboratories at the Lilly Medicine Foundry, driving phase-appropriate, risk-based analytical strategies from development through GMP execution. The position also oversees strategic planning across CMC analytical deliverables and partners cross-functionally to align analytical strategy with compliance, capability build, and digital enablement.