Bioprocess Scientist - Process Translation and Execution Lilly Medicine Foundry
Eli Lilly and Company
5 hours ago
On-site
Lebanon, IN
Operations
Responsibilities:
- Facilitate the transfer of biological processes (under appropriate supervisory guidance) from development laboratories to production operations, enabling transition to early-phase cGMP manufacturing of API required for clinical trial supply.
- Receive process information from research and development labs and translate it into production-scale execution in collaboration with operations, process engineering, quality, and health and safety.
- Order and stage raw materials.
- Collaborate in setting up analytical methods and analyze analytical data to make fact-based decisions.
- Summarize and present process results and challenges.
- Perform scale-down studies to support plant readiness and evaluate new technology at small scale, including upstream cell culture and downstream purification operations.
- Evaluate key raw materials to support process transfer/execution and confirm plant readiness.
- Maintain accurate lab notebooks documenting process steps, observations, and results.
- Documentation: author/review technical documents including process transfer plan, batch records, campaign summary reports, and deviation reports.
- Process improvement: apply scientific knowledge to identify improvements and implement new technologies/procedures.
- Support process troubleshooting and investigations by addressing process deviations, quality events, and non-conformances; collaborate on root cause analysis (RCA) and CAPAs.
Basic Requirements:
- B.S. or M.S. in biological sciences, chemical engineering, or related field.
- 2+ years of experience in manufacturing environments involving large molecule API or drug substance (preferred).
- Authorized to work in the United States on a full-time basis (Lilly does not sponsor visas).
Additional Skills and Preferences:
- Working knowledge of mammalian cell culture; primary recovery/purification unit operations; process optimization.
- Experience supporting multiple therapeutic modalities (e.g., ADC-related operations).
- Experience with development and scale-up of cell culture and purification process steps.
- Comfortable working with larger bioreactors and downstream equipment in a cGMP environment.
- Highly motivated; rapid learner; strong attention to detail.
- Experience creating batch records and executing processes according to them.
- Ability to prioritize multiple activities and manage ambiguity.
- Analytical data experience (e.g., HPLC/UPLC, SEC, CEX, CE-SDS, LC-MS).
- Ability to drive projects and accept change.
- Excellent written/verbal communication for reports, presentations, and cross-team collaboration.
- Strong problem-solving skills (data analysis, RCA, resolving technical challenges).
- Ability to work cross-functionally with operations, process engineers, analytical chemists, safety, and quality.
Benefits:
- Company bonus for full-time employees (depending on company/individual performance).
- Comprehensive benefits (including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Facilitate the transfer of biological processes (under appropriate supervisory guidance) from development laboratories to production operations, enabling transition to early-phase cGMP manufacturing of API required for clinical trial supply.
- Receive process information from research and development labs and translate it into production-scale execution in collaboration with operations, process engineering, quality, and health and safety.
- Order and stage raw materials.
- Collaborate in setting up analytical methods and analyze analytical data to make fact-based decisions.
- Summarize and present process results and challenges.
- Perform scale-down studies to support plant readiness and evaluate new technology at small scale, including upstream cell culture and downstream purification operations.
- Evaluate key raw materials to support process transfer/execution and confirm plant readiness.
- Maintain accurate lab notebooks documenting process steps, observations, and results.
- Documentation: author/review technical documents including process transfer plan, batch records, campaign summary reports, and deviation reports.
- Process improvement: apply scientific knowledge to identify improvements and implement new technologies/procedures.
- Support process troubleshooting and investigations by addressing process deviations, quality events, and non-conformances; collaborate on root cause analysis (RCA) and CAPAs.
Basic Requirements:
- B.S. or M.S. in biological sciences, chemical engineering, or related field.
- 2+ years of experience in manufacturing environments involving large molecule API or drug substance (preferred).
- Authorized to work in the United States on a full-time basis (Lilly does not sponsor visas).
Additional Skills and Preferences:
- Working knowledge of mammalian cell culture; primary recovery/purification unit operations; process optimization.
- Experience supporting multiple therapeutic modalities (e.g., ADC-related operations).
- Experience with development and scale-up of cell culture and purification process steps.
- Comfortable working with larger bioreactors and downstream equipment in a cGMP environment.
- Highly motivated; rapid learner; strong attention to detail.
- Experience creating batch records and executing processes according to them.
- Ability to prioritize multiple activities and manage ambiguity.
- Analytical data experience (e.g., HPLC/UPLC, SEC, CEX, CE-SDS, LC-MS).
- Ability to drive projects and accept change.
- Excellent written/verbal communication for reports, presentations, and cross-team collaboration.
- Strong problem-solving skills (data analysis, RCA, resolving technical challenges).
- Ability to work cross-functionally with operations, process engineers, analytical chemists, safety, and quality.
Benefits:
- Company bonus for full-time employees (depending on company/individual performance).
- Comprehensive benefits (including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation