Scientist

Job Summary

• 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.