Materials Management Scientist/Sr. Scientist/Principal Scientist - Process Translation and Execution - Lilly Medicine FoundryOrganization and Function OverviewLilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a pioneering center that integrates advanced manufacturing and drug development. As the first facility of its kind, the Foundry is designed to accelerate innovation in manufacturing processes, expand capacity for clinical trial medicines, and speed Lilly innovative medicine to Clinics, and reduce both costs and environmental impact.
The Process Translation and Execution (PTE) team plays a critical role in this mission. PTE is responsible for leading technology transfers from lab or pilot scale to cGMP production, collaborating with Operations and cross-functional teams to ensure reliable clinical supply and right-first-time production. The team also drives continuous improvement, advances the site technical agenda, and research transformative technologies and champions the accelerated adoption of innovation in clinical and commercial manufacturing, ultimately delivering patient-centric outcomes.
We are seeking enthusiastic scientists and engineers to join the PTE team and help bring the Lilly Medicine Foundry's vision to life.
Key Responsibilities:Serve as PTE's primary technical resource for chemical and raw material management, including:
- Chemical of concern' assessment and compliance with evolving federal and state regulations including evaluation of materials subject to REACH, TSCA, or international restrictions
- Provide written technical opinions and risk summaries to support site-level regulatory submissions, inspections, and internal audits.
Serve as PTE technical interface/advisor to the Supply Chain/Procurement organization:
- Support the creation and review of material specifications and liaise with supply chain, warehouse and analytical groups on sampling and testing plans.
- Coordinate with supply chain on the completion of material qualification activities including qualification of suppliers, technical review of regulatory documentation, certificates of analysis, and SDS accuracy.
- Assess the impact of supplier changes in collaboration with PTE scientists and provide input to change control documentation.
- Collaborate with PTE tech transfer lead and Procurement to identify preferred suppliers and flag single-source risks or supply chain vulnerabilities.
- Assist in developing and maintaining approved supplier lists (ASLs) for critical regulated materials in partnership with Process Development, Quality and Supply Chain.
- Participate in lifecycle management reviews for existing materials.
Provide technical support to tech transfer teams:
- Evaluate new chemical entities and reagents introduced for regulatory and classification implications prior to first-in-site use.
- Engage with Development early in technology transfer workflows to assess material management requirements for incoming programs across all Foundry modalities.
- Author or contribute to chemical management sections of tech transfer packages, process descriptions, and facility fit assessments.
- For process consumables, collaborate with process engineering on the site's Extractables and Leachables program, risk assessments and support start-up.
- Prepare, review, approve relevant technical documents such as change controls, deviation investigations, plant trial protocols and summary reports, procedures etc.
- Lead material investigations working with process teams to assess/investigate material issues, implement material changes and coordinate lab studies.
- Own or provide input to the material components of manufacturing execution systems, data management systems, technical reports etc.
Basic Requirements- Education: BS or MS in Biology, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related disciplines
- Experience: BS with 8+ years, or MS with 5+ years in Product/Process Development, Materials Coordination and Procurement, Manufacturing Technical Services, or related functional roles
Additional Skills and Preferences- Technical Expertise: Direct experience managing technical aspects of chemical and material compliance, including familiarity with applicable regulatory requirements and an understanding of compendial monographs and their relation to material specifications and testing, is strongly preferred. Strong knowledge of drug manufacturing processes.
- Problem-Solving Skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
- Communication Skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
- Collaboration: Demonstrated success in cross-functional, dynamic, and matrixed environments.
- Regulatory Knowledge: Solid understanding of biopharmaceutical manufacturing principles and cGMP requirements.
- Project Management: Experience leading small projects, coordinating activities, and managing timelines to meet project goals.
- Scientific Curiosity: Proactive engagement with external innovation and industry trends.
Other Information:- Current location, Carmel, IN. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Limited domestic and international travel (< 10%) may be required for this role
- Role requires ability to work in manufacturing and laboratory environments.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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.
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