Sr. Scientist – TSMS (R2–R4)
About The Position
Eli Lilly and Company seeks a Sr. Scientist – TSMS (R2–R4) to be responsible for providing technical support to manufacturing operations to ensure the reliable and compliant manufacture of bulk drug substances to predetermined global quality standards. Apply scientific principles to the manufacture of intermediates and bulk drug substances, ensuring a thorough understanding of the underlying chemistry and equipment interactions. Develop and maintain accurate master production records, standard operating procedures, and process-flow document that clearly describe the manufacturing process and outline the control strategy for the discrete manufacturing steps. Author and review relevant technical documents such as deviations, protocols, and summary reports. Develop, and monitor statistically based process metrics in real time to evaluate process variability and capability, and respond appropriately to observed trends. Drive change controls to support process improvement projects for manufacturing intermediates and bulk drug substances.
Requirements
- Bachelor’s degree in Chemical Engineering, Biotechnology or a related scientific field
- 2 years of experience in pharmaceutical manufacturing
- 1 year of experience with applying scientific principles to process understanding, problem solving, and process improvement
- 1 year of experience identifying and resolving manufacturing non-conformances, performing root cause analysis and authoring deviations
- 1 year of experience preparing, reviewing, and revising master production records (MPRs), standard operating procedures (SOPs), protocols, and summary reports
- 1 year of experience executing process-related change controls
- 1 year of experience applying statistical tools to monitor real-time process metrics and address observed process trends
Responsibilities
- Providing technical support to manufacturing operations to ensure the reliable and compliant manufacture of bulk drug substances to predetermined global quality standards.
- Applying scientific principles to the manufacture of intermediates and bulk drug substances, ensuring a thorough understanding of the underlying chemistry and equipment interactions.
- Developing and maintaining accurate master production records, standard operating procedures, and process-flow documents that clearly describe the manufacturing process and outline the control strategy for the discrete manufacturing steps.
- Authoring and reviewing relevant technical documents such as deviations, protocols, and summary reports.
- Developing and monitoring statistically based process metrics in real time to evaluate process variability and capability, and responding appropriately to observed trends.
- Driving change controls to support process improvement projects for manufacturing intermediates and bulk drug substances.
Benefits
- company bonus
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
