Scientist/Engineer - Technical Services/Manufacturing Science (Filling)
Eli Lilly and Company
5 hours ago
On-site
Durham, NC
Operations
Key Objectives / Deliverables
- Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
- Perform root cause analysis and apply scientific principles in response to manufacturing deviations.
- Provide technical support for start-up activities, including technology transfer and process validation.
- Author, review, approve, and provide technical support for technical documents (e.g., personnel qualification strategies, control strategies, investigations, change controls, procedures, master batch records, protocols and summary reports, technical studies, and regulatory submissions).
- Provide technical support for non-routine investigations (e.g., deviations and complaints).
- Ensure accurate instruction sets (manufacturing batch records & procedures) describe the process as performed and the control strategy for discrete manufacturing steps.
- Develop, monitor, and react to statistically based metrics in real-time to assess process variability and capability; apply process knowledge and data analysis to support daily manufacturing operations.
- Support and/or lead TS/MS technical projects to improve process control, yield, product quality and/or productivity; implement process changes and improvements.
- Serve as a technical interface external to the RTP site.
- Provide audit support.
- Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business plan and quality objectives.
- Collaborate with and influence partners across the Parenteral Network and product supply chain teams.
- Ensure a safe working environment by complying with safety rules and participating in safety-related activities.
Basic Requirements
- BS or MS in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Biochemistry, or related scientific discipline.
- Minimum 5 years of experience supporting cGMP manufacturing (e.g., Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance).
Additional Information (Role Expectations)
- Monday through Friday; must be flexible for business needs (production schedules, technical studies, shutdowns). Occasional extended/off-hour work may be required.
- Based out of RTP site; travel to Indianapolis and other global sites as required.
- Periodic on-call support for production required.
- Frequent presence on production floor (CNC/Grade C); office may be in a CNC area.
- Expected to be assigned to the filling process; may also support other process areas (e.g., formulation, visual inspection) as needed.
Benefits (as stated)
- Company-sponsored 401(k) and pension; vacation benefits.
- Medical, dental, vision, and prescription drug benefits.
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
- Life insurance and death benefits; certain time off and leave of absence benefits.
- Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Compensation (as stated)
- Anticipated wage: $66,000 - $171,600.
- Full-time employees may be eligible for a company bonus (depending on company and individual performance).
- Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
- Perform root cause analysis and apply scientific principles in response to manufacturing deviations.
- Provide technical support for start-up activities, including technology transfer and process validation.
- Author, review, approve, and provide technical support for technical documents (e.g., personnel qualification strategies, control strategies, investigations, change controls, procedures, master batch records, protocols and summary reports, technical studies, and regulatory submissions).
- Provide technical support for non-routine investigations (e.g., deviations and complaints).
- Ensure accurate instruction sets (manufacturing batch records & procedures) describe the process as performed and the control strategy for discrete manufacturing steps.
- Develop, monitor, and react to statistically based metrics in real-time to assess process variability and capability; apply process knowledge and data analysis to support daily manufacturing operations.
- Support and/or lead TS/MS technical projects to improve process control, yield, product quality and/or productivity; implement process changes and improvements.
- Serve as a technical interface external to the RTP site.
- Provide audit support.
- Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business plan and quality objectives.
- Collaborate with and influence partners across the Parenteral Network and product supply chain teams.
- Ensure a safe working environment by complying with safety rules and participating in safety-related activities.
Basic Requirements
- BS or MS in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Biochemistry, or related scientific discipline.
- Minimum 5 years of experience supporting cGMP manufacturing (e.g., Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance).
Additional Information (Role Expectations)
- Monday through Friday; must be flexible for business needs (production schedules, technical studies, shutdowns). Occasional extended/off-hour work may be required.
- Based out of RTP site; travel to Indianapolis and other global sites as required.
- Periodic on-call support for production required.
- Frequent presence on production floor (CNC/Grade C); office may be in a CNC area.
- Expected to be assigned to the filling process; may also support other process areas (e.g., formulation, visual inspection) as needed.
Benefits (as stated)
- Company-sponsored 401(k) and pension; vacation benefits.
- Medical, dental, vision, and prescription drug benefits.
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
- Life insurance and death benefits; certain time off and leave of absence benefits.
- Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Compensation (as stated)
- Anticipated wage: $66,000 - $171,600.
- Full-time employees may be eligible for a company bonus (depending on company and individual performance).