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Senior Manager QC

Make an impact in an exciting pharmaceutical company experiencing growth

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 currently looking to expand its resources to support Product Supply in the QC activities of its TransCon Growth Hormone program. The manufacturing processes of the TransCon Growth Hormone program are in the PPQ stage and are approaching the commercial phase.

As such, Ascendis Pharma is adding a Senior Manager QC to the Product Supply department. You will join a team of highly experienced colleagues working to reach Ascendis’ goals and you will report directly to the Senior Director for Drug Substance Manufacturing.

Your key responsibilities will be:

  • The coordination of analytical activities between Ascendis and CMOs on hGH and Drug Substance (DS) post-PPQ
  • Scientific and GMP-compliance review of analytical deviations and changes
  • Review and approval of analytical validation activities performed by the CMOs after PPQ and optimization of methods
  • Review of analytical validation, release, and stability testing incl. trending and control charts
  • Coordinate technical transfer both internal and external
  • Facilitate and support analytical performance and efficiency improvements
  • Establish procedures for internal review and handling of analytical data for commercial manufacturing
  • Write relevant sections of the regulatory documentation and follow-up on post-approval commitments to authorities
  • Keep abreast with scientific and regulatory development in areas of analytical testing, analytical methods, and analytical validation 

Your qualifications are several years of documented practical analytical experience from the pharmaceutical industry within protein analysis, either from an Analytical Development Laboratory or from a QC Laboratory. Furthermore, your knowledge and experience within protein analysis will enable you to guide project teams at CMOs, mainly placed within Europe. Preferably, you have analytical experience with analysis of protein and protein conjugate drug substance. Moreover, you are proficient in English, both written and spoken. 

You have a Master’s Degree in Biochemistry, Engineering, Pharmacy or the like.  

As a person, you are highly motivated and enjoy being challenged professionally. You have strong interpersonal skills and a proven ability to communicate with many stakeholders. You are flexible, adaptable and a robust person with a hands-on attitude. You think and manage strategically and pay attention to details. You are able to handle and deliver on routine jobs when necessary, while at the same time being able to move projects forward. Finally, you have a high level of energy, focus and passion.

Ascendis Pharma offers the candidate the possibility to create a meaningful impact on the organization’s success, while developing him/herself professionally. As Ascendis is growing rapidly, the company provides many opportunities for career and professional development.

Travelling: +/- 20 days per year.

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

For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25 or 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
T +45 7020 6700
/ /
cvr: 31502705
Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
+48 531 785 064
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ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland