Eli Lilly and Company
Bioprocess Scientist - Process Translation and Execution Lilly Medicine Foundry
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Bioprocess Scientist – Process Translation and Execution, Lilly Medicine Foundry
Join Eli Lilly and Company as a Bioprocess Scientist on the Process Translation and Execution (PTE) team at the Lilly Medicine Foundry, a $4.5 billion investment for advanced manufacturing and drug development. The PTE team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements control strategies, and ensures right‑first‑time manufacturing for synthetic molecules, biologics, peptides, oligonucleotides, and conjugates.
Responsibilities
Actively involved in receiving process information from research and development labs and translating that into execution at production scale in collaboration with operations, process engineering, quality, and health and safety groups.
Ordering and staging raw materials.
Collaborate in setting up analytical methods and analyzing analytical data to make fact‑based decisions.
Efficiently summarizing and presenting process results and challenges.
Perform scale‑down studies to ensure plant readiness and support evaluation of new technology at small‑scale for process steps including upstream cell culture and downstream purification operations at the Lilly Medicine Foundry.
Evaluate key raw materials to support process transfer and execution and confirm plant readiness.
Maintain accurate lab notebooks with accurate descriptions of process steps, observations, and results to support technical transfers into the production environment.
Documentation: Author, review technical documents, including the process transfer plan, batch records, campaign summary reports, and deviation reports.
Process improvement: Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.
Contribute to process troubleshooting and investigations by supporting process deviations, quality events, and non‑conformances. Collaborate with teams to perform root cause analysis (RCA) and develop effective corrective and preventive actions (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 is preferred.
Additional Skills and Preferences
Working knowledge of mammalian cell culture, primary recovery, and purification unit operations and process optimization.
Experience supporting multiple therapeutic modalities in addition to monoclonal antibodies, for example, antibody drug conjugate‑related operations.
Experience with development and scale‑up of cell culture and purification process steps.
Comfortable working with larger sized bioreactors and downstream‑related equipment in a cGMP regulated production environment.
Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
Experience creating batch records and process execution according to those records.
Ability to prioritize multiple activities and manage ambiguity.
Experience with analyzing data from a variety of analytical techniques, for example, HPLC/UPLC, SEC, CEX, CE‑SDS, LC‑MS, etc.
Demonstrated ability to drive projects and accept change.
Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
Problem‑solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
Ability to work cross‑functionally across disciplines and levels with operations, process engineers, analytical chemists, safety, and quality representatives.
Other Information Initial location: Lilly Technology Center, Indianapolis. Permanent location: Lilly Medicines Foundry, Lebanon, Indiana. Limited domestic and international travel ( Equal Employment Opportunity Lilly is a proud EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce; accommodations are available.
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Responsibilities
Actively involved in receiving process information from research and development labs and translating that into execution at production scale in collaboration with operations, process engineering, quality, and health and safety groups.
Ordering and staging raw materials.
Collaborate in setting up analytical methods and analyzing analytical data to make fact‑based decisions.
Efficiently summarizing and presenting process results and challenges.
Perform scale‑down studies to ensure plant readiness and support evaluation of new technology at small‑scale for process steps including upstream cell culture and downstream purification operations at the Lilly Medicine Foundry.
Evaluate key raw materials to support process transfer and execution and confirm plant readiness.
Maintain accurate lab notebooks with accurate descriptions of process steps, observations, and results to support technical transfers into the production environment.
Documentation: Author, review technical documents, including the process transfer plan, batch records, campaign summary reports, and deviation reports.
Process improvement: Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.
Contribute to process troubleshooting and investigations by supporting process deviations, quality events, and non‑conformances. Collaborate with teams to perform root cause analysis (RCA) and develop effective corrective and preventive actions (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 is preferred.
Additional Skills and Preferences
Working knowledge of mammalian cell culture, primary recovery, and purification unit operations and process optimization.
Experience supporting multiple therapeutic modalities in addition to monoclonal antibodies, for example, antibody drug conjugate‑related operations.
Experience with development and scale‑up of cell culture and purification process steps.
Comfortable working with larger sized bioreactors and downstream‑related equipment in a cGMP regulated production environment.
Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
Experience creating batch records and process execution according to those records.
Ability to prioritize multiple activities and manage ambiguity.
Experience with analyzing data from a variety of analytical techniques, for example, HPLC/UPLC, SEC, CEX, CE‑SDS, LC‑MS, etc.
Demonstrated ability to drive projects and accept change.
Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
Problem‑solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
Ability to work cross‑functionally across disciplines and levels with operations, process engineers, analytical chemists, safety, and quality representatives.
Other Information Initial location: Lilly Technology Center, Indianapolis. Permanent location: Lilly Medicines Foundry, Lebanon, Indiana. Limited domestic and international travel ( Equal Employment Opportunity Lilly is a proud EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce; accommodations are available.
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