Bioprocess Scientist (Downstream) - Advanced Therapies Manufacturing
Eli Lilly and Company
13 hours ago
On-site
Lebanon, IN
Operations
Position Description
Downstream Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) provides technical support for development, implementation, and technical transfer of compliant gene therapy drug substance manufacturing for clinical and commercial supply. Builds deep expertise in the science/process, operates equipment and control systems, and demonstrates data-driven decision-making and problem-solving. Ensures processes are in-control, capable, compliant, and validated through continual monitoring; may implement new technologies and process improvements.
Key Objectives/Deliverables
- In-depth knowledge of AAV/gene therapy science and process control strategy
- Technical support for tech transfer, process validation, investigations, and process stewardship/improvement
- Hands-on experience: chromatography, TFF, viral filtration, sterile filtration
- Bioprocess stewardship; lead RCA for deviations and impact assessments for changes
- Cross-functional partnership with operations/floor teams and development/engineering interfaces
- Assess process control/capability and maintain validated state
- Identify process improvements; support Lean initiatives
- Prepare/approve technical documents (change controls, regulatory submissions, deviation investigations, validation protocols/reports, processing records, process descriptions, annual reports)
- Support/lead technical projects for start-up, improving process control, yield, quality, and productivity
- Develop/monitor statistically based real-time metrics
- Serve as technical interface external to Lebanon site; provide audit support as needed
- Ensure safe work environment and improve safety culture
Basic Requirements
- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or related quantitative field
- 3+ years cGMP manufacturing experience (Operations, Validation, TS/MS, or Engineering)
Additional Preferences
- Gene therapy manufacturing; large-scale AAV single-use bioreactor production
- Solution filling and/or isolator technology; QC assay experience aligned to product CQAs
- Data trending/analysis; analyze complex data/problem-solving
- Interpersonal/teamwork; self-management/organization; clear oral/written communication
- Cross-functional team membership/leadership
Benefits (as stated)
- 401(k), pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits (EAP, fitness, clubs/activities)
- Eligible for company bonus (depending on performance)
Application instructions
- If you need an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Downstream Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) provides technical support for development, implementation, and technical transfer of compliant gene therapy drug substance manufacturing for clinical and commercial supply. Builds deep expertise in the science/process, operates equipment and control systems, and demonstrates data-driven decision-making and problem-solving. Ensures processes are in-control, capable, compliant, and validated through continual monitoring; may implement new technologies and process improvements.
Key Objectives/Deliverables
- In-depth knowledge of AAV/gene therapy science and process control strategy
- Technical support for tech transfer, process validation, investigations, and process stewardship/improvement
- Hands-on experience: chromatography, TFF, viral filtration, sterile filtration
- Bioprocess stewardship; lead RCA for deviations and impact assessments for changes
- Cross-functional partnership with operations/floor teams and development/engineering interfaces
- Assess process control/capability and maintain validated state
- Identify process improvements; support Lean initiatives
- Prepare/approve technical documents (change controls, regulatory submissions, deviation investigations, validation protocols/reports, processing records, process descriptions, annual reports)
- Support/lead technical projects for start-up, improving process control, yield, quality, and productivity
- Develop/monitor statistically based real-time metrics
- Serve as technical interface external to Lebanon site; provide audit support as needed
- Ensure safe work environment and improve safety culture
Basic Requirements
- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or related quantitative field
- 3+ years cGMP manufacturing experience (Operations, Validation, TS/MS, or Engineering)
Additional Preferences
- Gene therapy manufacturing; large-scale AAV single-use bioreactor production
- Solution filling and/or isolator technology; QC assay experience aligned to product CQAs
- Data trending/analysis; analyze complex data/problem-solving
- Interpersonal/teamwork; self-management/organization; clear oral/written communication
- Cross-functional team membership/leadership
Benefits (as stated)
- 401(k), pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits (EAP, fitness, clubs/activities)
- Eligible for company bonus (depending on performance)
Application instructions
- If you need an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation