Senior Scientist, MS&T
FLSA Status: Exempt
Position
Summary:
The primary function of a Sr. Scientist in the MS&T organization is to apply advanced science and technology for troubleshooting and improving commercial pharmaceutical manufacturing processes in a continuous manner.
Job responsibilities will also include partnering with quality organization to provide support for technically challenging complaints and ERs for timely closure. Independently identify, evaluate and implement potential process improvements and scrap reduction efforts. Lead new equipment and method implementation in CQ labs.
Will manage project activities directly, and provide oversight and guidance to support organizations.
Essential Duties &
Responsibilities:
1. Implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
2. Provide technical support for equipment and process validation activities, process overview training to support implementation of new process technologies, and process specifications to support defining the scope of capital projects.
3. Develop lists of potential process improvements; develop data packages by justifying and outlining recommendations for changes to or improvements in production processes, collaborating with technical staff to ensure consistency with corporate process technology initiatives.
4. Provide change management and implementation for changes to the manufacturing processes and associated systems, provide training for technical staff on major changes to processes, equipment and documentation.
5. Write technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancy and investigation.
6. Provide support for: discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures.
7. Use DOE in a scaled down setting to enable process troubleshooting.
8. Preview/provide feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, exception reports (ERs) etc.
9. Should be able to perform statistical analysis of the scientific data and provide recommendations.
10. Work on special projects as they arise.
Knowledge, Skills &
Qualifications:
Demonstrated understanding of program management required.
Demonstrated ability to effectively communicate complex scientific information to non-specialists required.
Education and
Experience:
Master's Degree is required:Masters in relevant scientific or engineering field.
PhD is preferred: Relevantscientific or engineering field (Chemical Engineering, Mechanical Engineering,Chemistry, Physics, Material Science, Physical Chemistry).
No less than 5 years ofindustry experience in Process Engineering or ManufacturingSciences and Technology or pharmaceutical industry preferred.
5 years of experience at amanufacturing site with 2
years in a pharmaceutical facility.
Minimum
Qualifications:
Must be at least 18 years of age
Must pass pre-employment drug screen and background check
Travel Requirements:
Typically requires travel less than 5% of the time
Physical Requirements and Work Environment:
Work is in an office, manufacturing area, or in lab settings.
Might require occasional lifting. Must be able to lift 20 lbs. unassisted.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.
ICU Medical, Inc. encourages individuals with disabilities to apply for positions of interest. If you need accommodations to complete the application process, please contact Human Resources at 949-366-3578.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Position
Summary:
The primary function of a Sr. Scientist in the MS&T organization is to apply advanced science and technology for troubleshooting and improving commercial pharmaceutical manufacturing processes in a continuous manner.
Job responsibilities will also include partnering with quality organization to provide support for technically challenging complaints and ERs for timely closure. Independently identify, evaluate and implement potential process improvements and scrap reduction efforts. Lead new equipment and method implementation in CQ labs.
Will manage project activities directly, and provide oversight and guidance to support organizations.
Essential Duties &
Responsibilities:
1. Implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
2. Provide technical support for equipment and process validation activities, process overview training to support implementation of new process technologies, and process specifications to support defining the scope of capital projects.
3. Develop lists of potential process improvements; develop data packages by justifying and outlining recommendations for changes to or improvements in production processes, collaborating with technical staff to ensure consistency with corporate process technology initiatives.
4. Provide change management and implementation for changes to the manufacturing processes and associated systems, provide training for technical staff on major changes to processes, equipment and documentation.
5. Write technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancy and investigation.
6. Provide support for: discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures.
7. Use DOE in a scaled down setting to enable process troubleshooting.
8. Preview/provide feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, exception reports (ERs) etc.
9. Should be able to perform statistical analysis of the scientific data and provide recommendations.
10. Work on special projects as they arise.
Knowledge, Skills &
Qualifications:
Demonstrated understanding of program management required.
Demonstrated ability to effectively communicate complex scientific information to non-specialists required.
Education and
Experience:
Master's Degree is required:Masters in relevant scientific or engineering field.
PhD is preferred: Relevantscientific or engineering field (Chemical Engineering, Mechanical Engineering,Chemistry, Physics, Material Science, Physical Chemistry).
No less than 5 years ofindustry experience in Process Engineering or ManufacturingSciences and Technology or pharmaceutical industry preferred.
5 years of experience at amanufacturing site with 2
years in a pharmaceutical facility.
Minimum
Qualifications:
Must be at least 18 years of age
Must pass pre-employment drug screen and background check
Travel Requirements:
Typically requires travel less than 5% of the time
Physical Requirements and Work Environment:
Work is in an office, manufacturing area, or in lab settings.
Might require occasional lifting. Must be able to lift 20 lbs. unassisted.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.
ICU Medical, Inc. encourages individuals with disabilities to apply for positions of interest. If you need accommodations to complete the application process, please contact Human Resources at 949-366-3578.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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