Advisor – Purification Process Translation and Execution
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Indianapolis • United States
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Salary
💰 $129,000 - $209,000 per year
About the role
- 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.
Requirements
- BS, MS or PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines
- 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
- Supervisory Experience: preferred
Benefits
- Participate in a company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- 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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
API processesBiologicsADCsTidescGMPbioprocessescell culturecentrifugationfiltrationchromatography
Soft Skills
troubleshootingdata analysisroot cause analysiswritten communicationverbal communicationcollaborationproject managementmentoringleadershipproblem-solving