Biopharmaceutical Technical Lead

2 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000

We are seeking a seasoned Biopharmaceutical Technical Lead to provide technical oversight for monoclonal antibody manufacturing processes. The successful candidate will leverage a strong technical foundation and previous experience supporting these processes.

The ideal candidate will participate in the resolution of technical issues, including those related to control strategy and manufacturing. They will possess excellent technical writing capabilities, authoring deviations and change controls, and employ excellent communication skills to manage internal and external relationships.

The Biopharmaceutical Technical Lead will build and maintain relationships with development and central technical organizations, ensuring that processes are compliant, capable, in control, and maintained in a validated or qualified state.

Key responsibilities include:

  • Providing technical oversight for monoclonal antibody manufacturing processes
  • Participating in the resolution of technical issues, including those related to control strategy and manufacturing
  • Authoring deviations and change controls
  • Employing excellent communication skills to manage internal and external relationships
  • Building and maintaining relationships with development and central technical organizations

Requirements:

  • Bachelor's degree in scientific disciplines such as biotechnology, chemistry, biochemistry, biology, pharmacy, or engineering
  • 3+ years of demonstrated hands-on working experience and proficiency with biopharmaceutical manufacturing and working knowledge of regulatory expectations
  • Strong understanding of regulatory requirements and their application in a manufacturing environment
  • Proficient in data management practices across manufacturing operations
  • Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change
  • Proven ability to effectively communicate and influence across diverse technical and business teams
  • Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects

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