Bioprocess Scientist - Process Translation and Execution Lilly Medicine Foundry
Eli Lilly and Company
8 hours ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Facilitate transfer of biological processes (under appropriate supervisory guidance) from development laboratories to production operations to enable early-phase cGMP manufacturing of API for clinical trial supply.
- Receive process information from R&D labs and translate into execution at production scale in collaboration with operations, process engineering, quality, and health & safety.
- Order and stage raw materials.
- Set up analytical methods; analyze analytical data to make fact-based decisions.
- Summarize and present process results and challenges.
- Perform scale-down studies to ensure plant readiness and support evaluation of new technology at small scale (upstream cell culture and downstream purification).
- 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.
- Troubleshooting/investigations: support process deviations, quality events, and non-conformances; collaborate on RCA and develop 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).
- Must be authorized to work in the United States full-time; Lilly does not sponsor work authorization/visas.
Additional Skills & Preferences:
- Working knowledge of mammalian cell culture, primary recovery/purification unit operations, and process optimization.
- Experience supporting multiple therapeutic modalities (e.g., antibody drug conjugate-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, learns rapidly, strong attention to detail.
- Experience creating batch records and executing processes according to them.
- Ability to prioritize multiple activities and manage ambiguity.
- Data analysis across techniques (HPLC/UPLC, SEC, CEX, CE-SDS, LC-MS, etc.).
- Ability to drive projects and accept change.
- Excellent written/verbal communication for technical 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.
Other Information (role logistics):
- Initial location: Lilly Technology Center, Indianapolis. Permanent location: Lilly Medicine Foundry, Lebanon, Indiana.
- Limited domestic/international travel (<5%). Role requires manufacturing and laboratory environment work.
- Facilitate transfer of biological processes (under appropriate supervisory guidance) from development laboratories to production operations to enable early-phase cGMP manufacturing of API for clinical trial supply.
- Receive process information from R&D labs and translate into execution at production scale in collaboration with operations, process engineering, quality, and health & safety.
- Order and stage raw materials.
- Set up analytical methods; analyze analytical data to make fact-based decisions.
- Summarize and present process results and challenges.
- Perform scale-down studies to ensure plant readiness and support evaluation of new technology at small scale (upstream cell culture and downstream purification).
- 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.
- Troubleshooting/investigations: support process deviations, quality events, and non-conformances; collaborate on RCA and develop 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).
- Must be authorized to work in the United States full-time; Lilly does not sponsor work authorization/visas.
Additional Skills & Preferences:
- Working knowledge of mammalian cell culture, primary recovery/purification unit operations, and process optimization.
- Experience supporting multiple therapeutic modalities (e.g., antibody drug conjugate-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, learns rapidly, strong attention to detail.
- Experience creating batch records and executing processes according to them.
- Ability to prioritize multiple activities and manage ambiguity.
- Data analysis across techniques (HPLC/UPLC, SEC, CEX, CE-SDS, LC-MS, etc.).
- Ability to drive projects and accept change.
- Excellent written/verbal communication for technical 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.
Other Information (role logistics):
- Initial location: Lilly Technology Center, Indianapolis. Permanent location: Lilly Medicine Foundry, Lebanon, Indiana.
- Limited domestic/international travel (<5%). Role requires manufacturing and laboratory environment work.