Scientist

Fresenius Kabi • Melrose Park, IL

3d

About The Position

Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc. Performs validations or verification of methods including transfer of methods to Quality Technologies or Quality Control or other testing laboratory. Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation. Manages stability program by execution of stability testing protocols, testing logistics for laboratory, providing stability summaries, finished product COA generation and provides updates to Regulatory Affairs and project team. Support Laboratory operation for instrument qualification. Ensures all technologies needed are available for project completion. Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in analytical method development, validation, and testing. Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems. Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements. Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule. Requires an eye for detail and repetitive precision in lab work and documentation.

Requirements

• Eye for detail
• Repetitive precision in lab work and documentation

Responsibilities

• Analytical Development
• Raw material release
• Stability testing
• Formulation testing
• Validations or verification of methods
• Transfer of methods to Quality Technologies or Quality Control or other testing laboratory
• Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation
• Manages stability program by execution of stability testing protocols, testing logistics for laboratory, providing stability summaries, finished product COA generation and provides updates to Regulatory Affairs and project team
• Support Laboratory operation for instrument qualification
• Plans, develops, and implements scientifically well-designed experimental programs
• Analytical method development
• Validation
• Testing
• Records experimental procedures, test results, and observations to meet corporate and GMP requirements
• Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule

What This Job Offers

• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees