Principal Scientist - Contamination Control Strategy
Eli Lilly and Company
6 hours ago
On-site
Lebanon, IN
Operations
Sr Principal Scientist, Contamination Control Strategy
Position Description
- Provide technical leadership for designing, deploying, and sustaining a contamination control strategy (CCS) at Lilly’s Lebanon API Manufacturing site.
- Ensure CCS alignment with technical, quality, and regulatory guidance, industry expectations, and business needs.
- Build technical expertise, apply data-driven decision-making, and continuously improve contamination control performance through innovative technologies.
- Serve as TS/MS (Technical Services) business SME; partner with process scientists and operations, and coordinate with Operations, Quality Control, Engineering, and Quality Assurance.
Key Objectives/Deliverables
- Work with CCS Advisor to integrate CCS into GMP operations and Lebanon API facility start-up; support ongoing GMP manufacturing.
- Author/review/approve technical documents (e.g., personnel qualification strategies, control strategies, investigations, change controls, procedures, technical studies) and support global CCS quality standards/tools implementation.
- Monitor and maintain cleanroom/controlled environment conditions and ensure compliant control strategies.
- Oversee routine environmental monitoring (EM); develop/monitor statistically based metrics for process variability and capability.
- Provide CCS technical support during start-up and post-Process Validation.
- Investigate contamination events/deviations; perform root cause analysis and implement CAPAs.
- Analyze trending data and prepare reports for management review.
- Train staff on contamination control, gowning, cleaning/sanitization, and cleanroom behavior.
- Collaborate with Quality, Engineering, and Operations to assess contamination risks and implement mitigation.
- Support internal and external audits related to contamination control.
Basic Requirements
- B.S. in Pharmacy, Science, Engineering, or related field.
- Minimum 6 years industry experience, including 3 years in GMP cleanroom manufacturing.
- Authorization to work in the United States on a full-time basis; Lilly does not sponsor work authorization/visas.
Preferences
- Deep technical understanding of CCS and regulatory expectations for facilities, production practices, environmental monitoring, and bioburden controls.
- Proficiency in data analysis; strong prioritization, attention to detail, decision-making, and complex problem-solving.
- Proven ability to work independently and collaboratively across cross-functional teams; respond proactively to changing priorities.
- Strong communication skills (oral and written).
Additional Information
- Fluent in English.
- Fully on-site in Lebanon, IN; standard 8-hour shift, 5 days/week; occasional nights/weekends may be required.
- Travel generally not exceeding 10%.
Compensation/Benefits (if applicable)
- Anticipated wage: $66,000 - $171,600.
- Full-time employees may be eligible for a company bonus.
- Comprehensive benefits program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
Position Description
- Provide technical leadership for designing, deploying, and sustaining a contamination control strategy (CCS) at Lilly’s Lebanon API Manufacturing site.
- Ensure CCS alignment with technical, quality, and regulatory guidance, industry expectations, and business needs.
- Build technical expertise, apply data-driven decision-making, and continuously improve contamination control performance through innovative technologies.
- Serve as TS/MS (Technical Services) business SME; partner with process scientists and operations, and coordinate with Operations, Quality Control, Engineering, and Quality Assurance.
Key Objectives/Deliverables
- Work with CCS Advisor to integrate CCS into GMP operations and Lebanon API facility start-up; support ongoing GMP manufacturing.
- Author/review/approve technical documents (e.g., personnel qualification strategies, control strategies, investigations, change controls, procedures, technical studies) and support global CCS quality standards/tools implementation.
- Monitor and maintain cleanroom/controlled environment conditions and ensure compliant control strategies.
- Oversee routine environmental monitoring (EM); develop/monitor statistically based metrics for process variability and capability.
- Provide CCS technical support during start-up and post-Process Validation.
- Investigate contamination events/deviations; perform root cause analysis and implement CAPAs.
- Analyze trending data and prepare reports for management review.
- Train staff on contamination control, gowning, cleaning/sanitization, and cleanroom behavior.
- Collaborate with Quality, Engineering, and Operations to assess contamination risks and implement mitigation.
- Support internal and external audits related to contamination control.
Basic Requirements
- B.S. in Pharmacy, Science, Engineering, or related field.
- Minimum 6 years industry experience, including 3 years in GMP cleanroom manufacturing.
- Authorization to work in the United States on a full-time basis; Lilly does not sponsor work authorization/visas.
Preferences
- Deep technical understanding of CCS and regulatory expectations for facilities, production practices, environmental monitoring, and bioburden controls.
- Proficiency in data analysis; strong prioritization, attention to detail, decision-making, and complex problem-solving.
- Proven ability to work independently and collaboratively across cross-functional teams; respond proactively to changing priorities.
- Strong communication skills (oral and written).
Additional Information
- Fluent in English.
- Fully on-site in Lebanon, IN; standard 8-hour shift, 5 days/week; occasional nights/weekends may be required.
- Travel generally not exceeding 10%.
Compensation/Benefits (if applicable)
- Anticipated wage: $66,000 - $171,600.
- Full-time employees may be eligible for a company bonus.
- Comprehensive benefits program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.