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Purification Process Translation and Execution Advisor
Advise on purification process transfer and execution across biologics, ADCs, and Tides. Support cGMP manufacturing, investigations, innovation, and technology transfer at Lilly facilities in Indianapolis and Lebanon.
संयुक्त राज्य$1,30,500 – $2,11,200 / वर्ष
ऑन-साइटपूर्णकालिकमध्य स्तरवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुवादकविवरण
- Transfer API and drug substance processes from development to the Foundry, with a focus on purification across biologics, ADCs, and Tides.
- Assess plant fit and scalability, and support right-first-time execution.
- Monitor manufacturing processes and analyze experimental and production data.
- Write technical reports, protocols, and change controls.
- Prepare and review technical documents, batch records, process descriptions, and risk assessments.
- Maintain compliance with cGMP and regulatory standards.
- Work with Foundry teams and PRD/CMC functions to meet project goals and product quality standards.
- Lead or support process investigations, evaluate deviations, design and conduct laboratory studies, and assist with CAPAs.
- Provide scientific input during audits and on-floor support for critical operations.
- Mentor or supervise junior scientists and technicians in laboratory procedures, data analysis, and PTE activities.
- Troubleshoot production issues, identify opportunities for improvement, and implement new technologies or procedures.
- Partner with PRD, Process Engineering, Tech Lilly, Digital Innovation, and internal, external, and academic collaborators to scout, evaluate, develop, and implement new technologies and methods.
आवश्यकताएँ
- Bachelor’s, master’s, or doctoral degree in biology, biochemistry, biological engineering, chemical or biochemical engineering, or a related discipline.
- At least 15 years of relevant experience with a bachelor’s degree, 10 years with a master’s degree, or 4 years with a doctorate in biologics or drug conjugate product or process development, manufacturing technical services, or a related function.
- Strong knowledge of bioprocesses, including cell culture, centrifugation, filtration, chromatography, conjugation, and aseptic processing.
- Demonstrated ability to analyze data, conduct root cause analysis, and resolve complex technical challenges.
- Excellent written and verbal communication skills, including technical report writing, presentations, and cross-team collaboration.
- Track record of success in cross-functional, dynamic, matrixed environments.
- Sound understanding of biopharmaceutical manufacturing principles and cGMP requirements.
- Proactive engagement with external innovation and industry trends.
- Experience leading small projects, coordinating activities, and managing timelines to meet project goals.
- Ability to work in manufacturing and laboratory environments.
- Limited domestic and international travel of less than 5% may be required.
- Supervisory experience is preferred.
लाभ
- Company bonus that depends in part on company and individual performance.
- Company-sponsored 401(k).
- Pension.
- Vacation benefits.
- Medical, dental, vision, and prescription drug coverage.
- Flexible benefits, including healthcare and dependent day care flexible spending accounts.
- Life insurance and death benefits.
- Certain time off and leave of absence benefits.
- Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
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