Biopharma Tech Transfer Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Blackswansexist Full time

We are partnering with a leading biopharma CDMO to expand their Tech Transfer team. This company has invested heavily in manufacturing capabilities and faces challenges in scaling their tech transfer processes.

This is a high-priority area within the organization, and the improvement work is sanctioned from senior leadership. As a Tech Transfer Lead, you will be involved in high-profile projects related to clinical and commercial products globally. This position offers solid career growth opportunities over the next 3-5 years, as few other companies are seeing similar levels of investment.

If you are an experienced Tech Transfer Lead or CMC Project Manager, we would be happy to discuss this opportunity in more detail.

Key Responsibilities:

  • Act as the main technical contact for customers and internal regulatory teams.
  • Develop project plans.
  • Implement Process Performance Qualification (PPQ) strategies tailored to each project.
  • Contribute to the establishment and implementation of global best practices for Technology Transfer and PPQ strategies.
  • Support CMC activities in development and manufacturing.
  • Identify and drive continuous improvement opportunities.
  • Identify and escalate project risks while tracking progress against milestones.

Requirements:

  • Masters Degree or above in engineering, chemistry, biochemistry, or similar.
  • 10+ years of experience in the pharma/biopharma industry, especially related to CMC Process Development and GMP manufacturing.


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