Senior Scientist – Manufacturing Science
Eli Lilly and Company
4 hours ago
On-site
Indianapolis, IN
Operations
Senior Scientist – Manufacturing Science
Responsibilities / Key Objectives / Deliverables:
- Provide technical support to achieve reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio (raw materials, intermediates, enzymes, bulk drug substances).
- Execute technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity.
- Set up and execute laboratory-scale experiments; conduct research for process improvements and troubleshooting in the TS/MS laboratory.
- Support technical documentation preparation (technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.).
- Develop and monitor real-time metrics to assess process variability and capability.
- Understand, justify, and document the state of validation (process and cleaning) with data demonstrating the process meets its stated purpose.
- Ensure instruction sets (tickets & procedures) and PFDs reflect the process as performed and the control strategy for discrete manufacturing steps.
- Support internal/joint process teams and global/local PLOT teams.
- Independently set up and execute chemical reactions; design well-structured experiments with clear objectives.
- Analyze data and ensure appropriate documentation; utilize safe lab practices and adhere to CHP requirements.
- Write technical reports and documents.
Basic Requirements:
- Bachelor’s degree in Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, or Analytical Chemistry.
- 3+ years of relevant industrial experience (API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development).
- Authorized to work in the United States full-time; Lilly does not sponsor visas.
Additional Preferences:
- Knowledge of small molecule API manufacturing; familiarity with cGMP terminology.
- Excellent analytical, interpersonal, written, and oral communication skills; independent and team-oriented.
- Ability to prioritize, demonstrate good judgment and flexibility.
Other Information:
- Tasks require entering manufacturing areas with appropriate PPE.
- Travel up to ~20%.
Benefits:
- Full-time employees may be eligible for a company bonus and a comprehensive benefits program (401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits).
Application Instructions:
- For workplace accommodation requests, complete: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities / Key Objectives / Deliverables:
- Provide technical support to achieve reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio (raw materials, intermediates, enzymes, bulk drug substances).
- Execute technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity.
- Set up and execute laboratory-scale experiments; conduct research for process improvements and troubleshooting in the TS/MS laboratory.
- Support technical documentation preparation (technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.).
- Develop and monitor real-time metrics to assess process variability and capability.
- Understand, justify, and document the state of validation (process and cleaning) with data demonstrating the process meets its stated purpose.
- Ensure instruction sets (tickets & procedures) and PFDs reflect the process as performed and the control strategy for discrete manufacturing steps.
- Support internal/joint process teams and global/local PLOT teams.
- Independently set up and execute chemical reactions; design well-structured experiments with clear objectives.
- Analyze data and ensure appropriate documentation; utilize safe lab practices and adhere to CHP requirements.
- Write technical reports and documents.
Basic Requirements:
- Bachelor’s degree in Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, or Analytical Chemistry.
- 3+ years of relevant industrial experience (API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development).
- Authorized to work in the United States full-time; Lilly does not sponsor visas.
Additional Preferences:
- Knowledge of small molecule API manufacturing; familiarity with cGMP terminology.
- Excellent analytical, interpersonal, written, and oral communication skills; independent and team-oriented.
- Ability to prioritize, demonstrate good judgment and flexibility.
Other Information:
- Tasks require entering manufacturing areas with appropriate PPE.
- Travel up to ~20%.
Benefits:
- Full-time employees may be eligible for a company bonus and a comprehensive benefits program (401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits).
Application Instructions:
- For workplace accommodation requests, complete: https://careers.lilly.com/us/en/workplace-accommodation