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Process Development Specialist

1 week ago

Portlaoise, Laois, Ireland Life Science Recruitment Full time

We are seeking a talented Process Development Specialist to join our team at Life Science Recruitment. This is an exceptional opportunity for individuals looking to work with a leading Biopharmaceutical organization.

The successful candidate will be responsible for developing and executing technology transfer, process, and clean validation programs in line with company, industry, and regulatory standards. They will participate in and lead key technology transfers activities, supporting clinical and commercial new product introduction projects.

Key Responsibilities
  • Program Execution: Execute technology transfer, process, and clean validation programs in line with company, industry, and regulatory standards.
  • Strategy Development: Develop strategies for technology transfer and process validation programs.
  • Subject Matter Expert: Act as a Subject Matter Expert in the support of process investigations.
  • Risk Management: Use risk management techniques to assess strategies, prioritize activities, and initiatives.
  • Project Leadership: Lead other significant business-critical projects on site associated with new product introduction and site capability build.
  • Equipment Optimization: Ongoing optimization of process equipment and development of future breakthrough business solutions.

Requirements:

  • Experience: Experience in a biologics drug substance environment.
  • Technical Expertise: Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
  • Tech Transfer Experience: Experience in technology transfers for clinical or commercial biologics strongly desired.
  • Automated Systems: Experience with automated systems highly desired.
  • Process Validation: Process validation and cleaning validation experience desired.