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CMC Project Manager Drug Product

CMC Project Manager in a fast-growing Biotech company.

Ascendis Pharma is an entrepreneurial and fast-growing company where skilled, agile and highly resourceful professionals can truly make their mark. Ascendis offers a dynamic place for employees to grow and develop their skills, while influencing the direction of this global company. Ascendis Pharma is in the process of expanding its pipeline with more drug candidates and is putting considerable emphasis on the further clinical development of its own products.

As CMC Project Manager 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.

This is a once-in-a-lifetime opportunity  to become a major participant in the further development of Ascendis’ TransCon CNP drug product.  

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 with CMOs
  • Ensuring that the drug product activities are conducted optimally with respect to quality, timelines, and budget
  • Writing regulatory quality documentation
  • Reporting on project progress via line management and project review meetings

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

Your qualifications include solid experience within the field of pharmaceutical & process development. You have experience with formulation and manufacturing of peptide and protein pharmaceuticals. You possess in-depth knowledge within regulatory requirements for peptide and/or protein injectables. You have experience with the outsourcing of CMC drug product activities, as well as experience with lyophilized peptide and/or protein drug products. Finally, you have experience with liquid peptide and/or protein injectables.

You are you have a high level of drive, ambition, and passion. You take initiative, are persistent,  pay a high level of attention to detail 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, pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You are proficient in English at a professional level, both written and spoken, and you master MS Office.

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 work with highly skilled and experienced colleagues to advance Ascendis’ 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 submitted in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
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