Scientist

Fresenius Kabi • Melrose Park, IL

11h

About The Position

The Scientist, Analytical Development conducts all aspects of Analytical Development including method development, experimentation, and record keeping. The incumbent must be able to develop and implement methods that meet project needs. The position is responsible for conducting analytical development studies with increasing complexity in nature and solving problems to ensure a robust method can be performed in the laboratory.

Requirements

• Method development
• Experimentation
• Record keeping
• Develop and implement methods that meet project needs
• Conduct analytical development studies with increasing complexity
• Solve problems to ensure a robust method can be performed in the laboratory
• Perform 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
• Manage stability program
• Execution of stability testing protocols
• Testing logistics for laboratory
• Providing stability summaries
• Finished product COA generation
• 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
• Demonstrates creativity and capability in analytical method development, validation, and testing
• Identifies problem areas
• 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
• Keeps assignment completion on schedule
• Requires an eye for detail and repetitive precision in lab work and documentation

Responsibilities

• 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.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• 401K with company contribution
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed