Advisor - Purification Process Translation and Execution Lilly Medicine Foundry
About The Position
Lilly Medicine Foundry is a pioneering center integrating advanced manufacturing and drug development, designed to accelerate innovation in manufacturing processes, expand capacity for clinical trial medicines, and speed innovative medicines to clinics while reducing costs and environmental impact. The Process Translation and Execution (PTE) team is critical to this mission, responsible for leading technology transfers from lab or pilot scale to cGMP production. The team ensures reliable clinical supply and right-first-time production, drives continuous improvement, advances the site technical agenda, and researches transformative technologies to accelerate the adoption of innovation in clinical and commercial manufacturing, ultimately delivering patient-centric outcomes. This role involves working with scientists and engineers to bring the Lilly Medicine Foundry’s vision to life.
Requirements
- 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
- Strong knowledge of bioprocesses (upstream or downstream, including cell culture, centrifugation, filtration, chromatography, conjugation, and aseptic processing).
- Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
- Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
- Demonstrated success in cross-functional, dynamic, and matrixed environments.
- Solid understanding of biopharmaceutical manufacturing principles and cGMP requirements.
- Proactive engagement with external innovation and industry trends.
- Experience in leading small projects, coordinating activities, and managing timelines to meet project goals.
Nice To Haves
- Supervisory Experience
- Experience in leading small projects, coordinating activities, and managing timelines to meet project goals.
Responsibilities
- 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.
- Apply scientific knowledge to troubleshoot production issues, identify areas for improvement, design and conduct lab studies, and implement new technologies or procedures.
- Monitor manufacturing processes, analyze experimental and production data, and author technical reports, protocols, and change controls.
- Support the creation and review of technical documents, batch records, process descriptions, and risk assessments, ensuring adherence to cGMP and regulatory standards.
- Work closely with various functions within Foundry and across PRD/CMC to achieve project goals and ensure product quality.
- 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.
- 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.
- 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.
Benefits
- company bonus
- company-sponsored 401(k)
- pension
- vacation benefits
- 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
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
