Biologics Process Validation Leader

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BSc in Scientific Discipline
• Minimum 5 years' demonstrated experience in the Pharmaceutical Industry in leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.
  
  

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experienced in process validation at commercial scale and bench scale.
• Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
• Excellent problem solver and ability to think and work creatively.  
• Demonstrated knowledge of Quality by Design and risk management approaches.
• Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
• Broad and integrated knowledge that can impact project and workgroup direction.  Working knowledge of regulatory requirements in the industry and drug development.
• Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.
• Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.
• Ability to support due diligences.