Analytical Transfer and Validation Specialist

Responsibilities :

• Manage comprehensive validation studies to ensure the performance of analytical methods 
• Write and review analytical transfer/validation/verification protocols, data, reports, test methods and other related documentation 
• Analyze and interpret results of validation studies and prepare detailed reports 
• Act as technical expert in analytical matters for several projects within the department 
• Develop new analytical methods as part of the product development program.
• Manage the implementation of new raw materials by defining the required tests

Profil : 

• Scientific background in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experiences, in a GMP environment
• At least 4 years' experience in project management, analytical transfer and validation
• Perfect knowledge of ICH guidelines on analytical methods, stability, comparability and specification
• Fluent in French and English