Biologics Virus Clearance Validation Leader

• Uses regulatory guidance and industry best practice, and scientific and technical experience, to develop innovative approaches to process or viral clearance or process validation.
• Plans, executes and reports process or viral clearance validation studies through process sciences, CROs, internal NPI or commercial DS sites or strategic CDMOs.
• Authors regulatory submissions, responds to health authority information requests and presents at pre-approval & cGMP inspections as necessary.
• Participates in deviation, change & continuous improvement evaluations in support of continued lifecycle verification.
• Participates in the development & implementation of new process and analytical manufacturing technologies in support of biologics DS processes.
• Manages CRO or CDMO contracts, and the effective management of expenditure and effort in support of viral clearance or process validation studies.
• Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.
• Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D.
  
  

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, bench scale, and in terms of virus clearance.
• 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.