Bioprocess Scientist - Process Translation and Execution Lilly Medicine Foundry
Eli Lilly and Company, Lebanon, IN, United States
The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase‑appropriate control strategies, and ensures right‑first‑time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates.
During the Foundry Construction and Project Delivery/Startup Phase (2025‑2028), the role is fluid and dynamic. Success requires collaboration, creativity, and resilience.
Responsibilities
Receive process information from research and development laboratories and translate that into execution at production scale in collaboration with operations, process engineering, quality, and health and safety groups.
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 efficiently.
Perform scale‑down studies to ensure plant readiness and support evaluation of new technology at small scale, 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 descriptions of process steps, observations, and results to support technical transfers into the production environment.
Document by authoring and reviewing technical documents, including the process transfer plan, batch records, campaign summary reports, and deviation reports.
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 and develop effective corrective and preventive actions (CAPAs).
Basic Requirements
B.S. or M.S. in biological sciences, chemical engineering, or a related field.
2+ years of experience in manufacturing environments involving large‑molecule API or drug substance (preferred).
Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.
Additional Skills and Preferences
Working knowledge of mammalian cell culture, primary recovery and purification unit operations, and process optimization.
Experience supporting multiple therapeutic modalities beyond 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 executing processes 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.
Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
Proven problem‑solving skills and ability to 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 ( Role requires the ability to work in manufacturing and laboratory environments.
Compensation Actual compensation depends on education, experience, skills, and geographic location. Anticipated wage: $66,000 – $171,600 per year.
Benefits Full‑time employees are eligible for a comprehensive benefit program, including a company‑sponsored 401(k), pension, vacation, medical, dental, vision, and prescription drug benefits, flexible benefits such as healthcare and/or dependent day‑care flexible spending accounts, life insurance, death benefits, time off and leave of absence benefits, and well‑being benefits such as employee assistance programs, fitness benefits, and employee clubs and activities.
EEO Statement Lilly is proud to be an 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.
Accommodation Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. If you require accommodation to submit a resume or during the application process, please complete the accommodation request form.
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During the Foundry Construction and Project Delivery/Startup Phase (2025‑2028), the role is fluid and dynamic. Success requires collaboration, creativity, and resilience.
Responsibilities
Receive process information from research and development laboratories and translate that into execution at production scale in collaboration with operations, process engineering, quality, and health and safety groups.
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 efficiently.
Perform scale‑down studies to ensure plant readiness and support evaluation of new technology at small scale, 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 descriptions of process steps, observations, and results to support technical transfers into the production environment.
Document by authoring and reviewing technical documents, including the process transfer plan, batch records, campaign summary reports, and deviation reports.
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 and develop effective corrective and preventive actions (CAPAs).
Basic Requirements
B.S. or M.S. in biological sciences, chemical engineering, or a related field.
2+ years of experience in manufacturing environments involving large‑molecule API or drug substance (preferred).
Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.
Additional Skills and Preferences
Working knowledge of mammalian cell culture, primary recovery and purification unit operations, and process optimization.
Experience supporting multiple therapeutic modalities beyond 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 executing processes 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.
Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
Proven problem‑solving skills and ability to 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 ( Role requires the ability to work in manufacturing and laboratory environments.
Compensation Actual compensation depends on education, experience, skills, and geographic location. Anticipated wage: $66,000 – $171,600 per year.
Benefits Full‑time employees are eligible for a comprehensive benefit program, including a company‑sponsored 401(k), pension, vacation, medical, dental, vision, and prescription drug benefits, flexible benefits such as healthcare and/or dependent day‑care flexible spending accounts, life insurance, death benefits, time off and leave of absence benefits, and well‑being benefits such as employee assistance programs, fitness benefits, and employee clubs and activities.
EEO Statement Lilly is proud to be an 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.
Accommodation Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. If you require accommodation to submit a resume or during the application process, please complete the accommodation request form.
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