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Drug Development Project Manager

2 weeks ago

Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

We are seeking an experienced Project Manager to lead a new drug development project within Biologics (Mammalian) in cooperation with a Contract Development and Manufacturing Organization (CDMO).

The successful candidate will work closely with cross-functional teams preparing project plans and executing the Critical Quality Attributes (CQA) activities.

The role involves chairing the CMC project team, ensuring clear direction and communication, and cross-functional cooperation and alignment. The individual must be able to develop and maintain the CMC project plan, timeline, and budget and oversee the progress of our internal CMC activities.

The ideal candidate has a master's degree in engineering, natural science, or equivalent, with minimum 5 years of experience within drug development, Biologics. They should have proven project manager skills from a development environment and the ability to lead cross-functional teams.

The selected candidate will represent the Global CMC area in the Project Core Team and report to the Vice President, Pharmaceutical Development. They will be responsible for overseeing the relationship and communication with the CDMO, ensuring alignment with project timelines, deliverables, and regulatory requirements.

Key responsibilities include:

  • Chairing the CMC project team and ensuring clear direction and communication
  • Developing and maintaining the CMC project plan, timeline, and budget
  • Oversseeing the progress of internal CMC activities
  • Representing G-CMC in the Project Core Team
  • Overseeing the relationship and communication with the CDMO