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Biologics Processing Manager

2 weeks ago

Portlaoise, Laois, Ireland Quanta Consultancy Services Ltd Full time

About the Job

This is a unique opportunity to join Quanta Consultancy Services Ltd as a Biologics Processing Manager in Dublin, Ireland. You will be working on a fast-paced project that involves working with cutting-edge technologies and developing your skills.

Key Responsibilities

  • Participate in and lead technology transfer activities, supporting clinical and commercial new product introduction projects.
  • Develop strategies for process validation programs and execute them in line with company, industry, and regulatory standards.
  • Act as a process subject matter expert, supporting process investigations and using risk management techniques to prioritize activities and initiatives.
  • Lead significant business-critical projects on site associated with new product introduction and site capability build.

Requirements

  • Minimum of a Bachelor's Level 8 degree in a technical field (e.g., Engineering, Science, or equivalent).
  • Extensive experience in a biologic drug substance environment.
  • Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
  • Experience in technology transfers for clinical or commercial biologics strongly desired.
  • Experience with automated systems highly desired.
  • Process validation and cleaning validation experience desired.