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CMC Project Manager Drug Product

CMC Project Manager in a fast-growing biotech company

Ascendis Pharma, a visionary and ambitious company, offers you an opportunity to become a major participant in the further development and expansion of the current clinical stage TransCon drug products.

As CMC Project Manager Drug Product at Ascendis Pharma, the main success criteria is to create a good understanding of deliverables to the project from the CMC project team members and to be able to establish a close and high-standard cooperation with the CMC project team within Ascendis Pharma. Moreover, it is also a criteria of sucesses to be able to establish close and high-standard cooperation with the CMOs used by Ascendis Phama in order to become a value-adding resource to them.

You report directly to the VP, CMC Pharmaceutical & Device Development and will be part of a very dedicated and experienced team.

Your main responsibilites are:

  • Designing, executing and reporting pharmaceutical development studies
  • Planning, executing and reviewing drug product manufacturing campaigns together with CMOs
  • Ensure that the drug product activities are conducted optimally with respect to quality, timelines and budget
  • Writing regulatory quality documentation
  • Report on project progress via line management and project review meetings

You hold a relevant academic degree – preferably a Master of Science in Pharmacy, Chemistry, Engineering or the like. A PhD is preferred but not a demand.

The following qualifications are prefered:

  • Several years of experience within the field of pharmaceutical and process development
  • Experience with formulation and manufacturing of peptide and protein pharmaceuticals
  • Knowledge within regulatory requirements for peptide and/or protein injectables
  • Experience within outsourcing of CMC drug product activities
  • Experience with lyophilized peptide and/or protein drug products
  • Experience with liquid peptide and/or protein injectables

You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You have a high level of drive, ambition, and passion. You take initiative, are persistent, pay a high level of attention to details and you are goal-oriented. You are comfortable with a risk-based approach to decision-making in a dynamic environment in which priorities and drivers can change rapidly. You are flexible and pragmatic with an open and communicative approach and you have the ability to develop effective working relationships with employees at all levels.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and you will work together with highly skilled and experienced colleagues to advance the exciting product pipeline.

Travelling: 10 – 20 days/year

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.

For more details about the job or the company, please contact Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
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