CMC Project Director

3 days ago


Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

We are looking for a Senior CMC Project Manager to join our Global CMC-Development team at ALK-Abelló A/S. As a key member of the team, you will be responsible for managing projects in different phases, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.

Your key responsibilities will include:

  • Leading cross-functional teams to prepare project plans and execute CMC activities.
  • Ensuring clear direction and communication, as well as cross-functional cooperation and alignment.
  • Developing and maintaining CMC project plans, timelines, and budgets, and overseeing the progress of internal CMC activities.
  • Representing G-CMC in the Project Core Team and ensuring CMC deliverables are aligned with overall project expectations, and managing stakeholders.
  • Overseeing the relationship and communication with our CDMO, ensuring alignment with project timelines, deliverables, CDMO budget, and regulatory requirements.
  • Identifying potential CMC project risks and issues and proactively implementing mitigation strategies.

Our ideal candidate should have:

  • An educational background with a master's degree in engineering, natural science, or equivalent.
  • Minimum 5 years of experience within drug development, Biologics.
  • Proven project management skills from a development environment and ability to lead cross-functional teams.
  • Good analytical skills and ability to focus on the critical path and prepare mitigation strategies.
  • Adaptability and solution-orientedness, ready to lead the project team to success with a high scientific standard.
  • Strong communication skills and fluency in English, both orally and in writing.
  • Preferably experience within drug development, regulatory filings, and requirements.


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