Biologics Virus Clearance Validation Leader

4 weeks ago


Dubai, Dubai, United Arab Emirates GSK Full time
Job Description

We are seeking a highly skilled Biologics Virus Clearance Validation Leader to join our team at GSK. As a key member of our process sciences team, you will be responsible for developing innovative approaches to process or viral clearance or process validation.

Key Responsibilities
  • Develop and execute process validation strategies for biologics products.
  • Plan, execute, and report processor viral clearance validation studies.
  • Author regulatory submissions and respond to health authority information requests.
  • Participate in deviation, change, and continuous improvement evaluations.
  • Manage CRO or CDMO contracts and expenditure.
  • Provide technical leadership and establish key relationships with operational teams.
Requirements
  • BSc in Scientific Discipline.
  • Minimum 5 years' experience in the Pharmaceutical Industry in leading technical aspects of the product lifecycle.
Preferred Qualifications
  • Experience in process validation at commercial scale, bench scale, and in terms of virus clearance.
  • Knowledge of current and emerging Regulatory Strategies.
  • Excellent problem-solving skills and ability to think creatively.
  • Demonstrated knowledge of Quality by Design and risk management approaches.
  • Broad and integrated knowledge of biopharmaceutical production processes.


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