Bioprocess Scientist (Drug Product) - Advanced Therapies Manufacturing
Eli Lilly and Company
14 hours ago
On-site
Lebanon, IN
Operations
Position Description
Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist (TS/MS)
Role Responsibilities / Key Objectives/Deliverables
- Provide technical support for internal and external TS/MS activities (tech transfer, process validation, investigations, media & buffer recipe, formulation, filling & packaging, visual inspection).
- Apply scientific principles for manufacturing gene therapy drug products (chemistry, equipment, aseptic processes, container closure systems).
- Ensure formulation issues are addressed and resolved.
- Own and provide technical stewardship of media and buffer preparation formulations.
- Prepare/review/approve technical documents (change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process descriptions, annual reports).
- Support/lead TS/MS projects to improve start-up success, process control, yield, product quality, and/or productivity; implement process improvements.
- Develop/monitor statistically based real-time metrics to assess variability and capability.
- Use process knowledge and data analysis to support daily manufacturing operations.
- Serve as technical interface external to the Lebanon site; provide audit support as needed.
- Work with/lead cross-functional teams; ensure a safe working environment and participate in safety activities.
Basic Requirements
- BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or related quantitative field.
- 3+ years cGMP manufacturing experience (Operations, Validation, TS/MS, Engineering, or Quality Assurance).
- 3+ years parenteral drug product manufacturing experience (formulation, tech transfer, visual inspection, statistical data trending/analysis, process risk assessment such as FMEA).
Additional Preferences
- In-depth knowledge of gene therapy drug product manufacturing.
- AAV formulation; media and buffer preparation experience.
- Solution filling equipment and/or isolator technology experience.
- Serialization and packaging experience.
- Interpersonal/teamwork, self-management/organization, strong oral and written communication.
- Data trending/analysis; ability to analyze complex data and solve problems.
- Proven membership/leadership in cross-functional teams.
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist (TS/MS)
Role Responsibilities / Key Objectives/Deliverables
- Provide technical support for internal and external TS/MS activities (tech transfer, process validation, investigations, media & buffer recipe, formulation, filling & packaging, visual inspection).
- Apply scientific principles for manufacturing gene therapy drug products (chemistry, equipment, aseptic processes, container closure systems).
- Ensure formulation issues are addressed and resolved.
- Own and provide technical stewardship of media and buffer preparation formulations.
- Prepare/review/approve technical documents (change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process descriptions, annual reports).
- Support/lead TS/MS projects to improve start-up success, process control, yield, product quality, and/or productivity; implement process improvements.
- Develop/monitor statistically based real-time metrics to assess variability and capability.
- Use process knowledge and data analysis to support daily manufacturing operations.
- Serve as technical interface external to the Lebanon site; provide audit support as needed.
- Work with/lead cross-functional teams; ensure a safe working environment and participate in safety activities.
Basic Requirements
- BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or related quantitative field.
- 3+ years cGMP manufacturing experience (Operations, Validation, TS/MS, Engineering, or Quality Assurance).
- 3+ years parenteral drug product manufacturing experience (formulation, tech transfer, visual inspection, statistical data trending/analysis, process risk assessment such as FMEA).
Additional Preferences
- In-depth knowledge of gene therapy drug product manufacturing.
- AAV formulation; media and buffer preparation experience.
- Solution filling equipment and/or isolator technology experience.
- Serialization and packaging experience.
- Interpersonal/teamwork, self-management/organization, strong oral and written communication.
- Data trending/analysis; ability to analyze complex data and solve problems.
- Proven membership/leadership in cross-functional teams.
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation