Organization 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:- Process Transfer and Production Support: Oversee the successful transfer of API/DS processes from development to Foundry with a focus on purification and flexibility in supporting multiple modalities, including Biologics, ADCs, Tides, ensuring process fit to plant, scalability, and right-first-time execution.
- Data Analysis and Reporting: Monitor manufacturing processes, analyze experimental and production data, and author technical reports, protocols, and change controls.
- Documentation and Compliance: Support the creation and review of technical documents, batch records, process descriptions, and risk assessments, ensuring adherence to cGMP and regulatory standards.
- Cross-Functional Collaboration: Work closely with various functions within Foundry and across PRD/CMC to achieve project goals and ensure product quality.
- Investigations and CAPA Support: Lead or assist in process-related investigations, assess deviations, design and conduct needed lab studies, and support Corrective and Preventive Actions (CAPAs) to maintain product quality and timelines.
- Technical Expertise: Provide scientific input during audits, provide on-floor support for critical operations, and mentor or supervise junior scientists or technicians in laboratory procedures, data analysis and related PTE activities.
- Continuous Improvement: Apply scientific knowledge to troubleshoot production issues, identify areas for improvement, design and conduct lab studies, and implement new technologies or procedures.
- Site Technology Agenda & Innovation: Collaborate with PRD, Process Engineering, and leverage internal/external/academic partnerships to accelerate innovation, including scouting, assessing, developing, and implementing new technologies. Collaborate with Tech Lilly and Digital Innovation to contribute to identification and implementation of transformative technologies and methodologies to accelerate technology transfer, minimize translation errors, and drive continuous improvement.
Basic Requirements- Education: BS, MS or PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines
- Experience: BS with 15+ years, or MS with 10+ years, or PhD with 4+ years in Biologics/Drug Conjugates Product/Process Development, Manufacturing Technical Services, or related functional roles
Additional Skills and Preferences- Technical Expertise: Strong knowledge of bioprocesses (upstream or downstream, including cell culture, centrifugation, filtration, chromatography, conjugation, and aseptic processing).
- 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.
- Scientific Curiosity: Proactive engagement with external innovation and industry trends.
- Project Management: Experience in leading small projects, coordinating activities, and managing timelines to meet project goals.
- Supervisory Experience: preferred
Other Information:- Initial location at Lilly Technology Center, Indianapolis and/or Parkwood West
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Limited domestic and international travel (< 5%) 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
$130,500 - $211,200
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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