Biotech Validation Manager

4 weeks ago

London, Greater London, United Kingdom Life Science People Full time
Job Overview

We are seeking a highly skilled Biotech Validation Manager to join our team at Life Science People. As a key member of our Quality Assurance department, you will play a critical role in ensuring the development and validation of analytical test methods for our gene therapy products.

Key Responsibilities:

  • Lead the development and validation of analytical test methods for current and newly developed gene therapy products.
  • Act as the subject matter expert for lifecycle management of analytical assays, equipment, and materials.
  • Develop and manage qualification/validation projects, ensuring all supporting documentation aligns with compliance requirements.
  • Ensure all methods are validated and executed in QC GMP laboratories, adhering to regulatory standards and data integrity requirements.
  • Support the validation of methods for raw material testing and sampling booth activities.
  • Manage the implementation of test methods, ensuring timelines are met to facilitate the seamless launch of new products.
  • Oversee external testing activities to ensure compliance with GMP standards.
  • Maintain effective communication with key stakeholders, ensuring the timely update of information folders with the latest versions and relevant communications.
  • Facilitate the development and delivery of training on new technologies or methodologies introduced to the facility.
  • Conduct routine assessments of analytical methods to ensure their proper application and performance.

Requirements:

  • Degree in Human Health or Sciences equivalent relevant work experience.
  • Experience in a validation role in the Biotech or Pharma industry.
  • Previously managed a team.
  • Experience working on several projects.
  • 5+ years of experience working in a GMP environment.
  • Willing to occasionally travel to Ireland.

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