Senior Specialist, Drug Product QC

Senior Specialist, Drug Product QC

Ascendis Pharma

Hellerup, Denmark

We are seeking an experienced Senior Specialist to join our growing team. As a key member of the Ascendis Pharma QC team, you will play a central role in coordinating analytical matters between Ascendis and different Contract Manufacturing Organizations (CMOs) as well as establishing and maintaining oversight over stability studies. You will be involved in all aspects of QC testing and handling of stability studies at our CMOs including validation, trouble shooting, trending and optimization. As we are currently submitting our products in many countries preparing regulatory documentation and answering questions from different authorities will be a part of the job. So, the success criterion in the job will be to ensure continuous good relations and alignment with CMOs and to ensure that analytical activities are executed according to regulatory requirements and in a scientifically sound manner. You will join the Drug Product QC team of five colleagues and report to Senior Director Lars Bo Ekhart Jensen, based in Hellerup. 

Your key responsibilities will be:

• Oversight and coordination of analytical activities at the CMOs;
• Support the CMOs in decisions regarding the analytical methods e.g. validation strategy, laboratory investigations, method optimization;
• Give input or participate directly with the CMO in trouble shooting in connection with adverse events in the laboratory;
• Planning and follow up on projects initiated at the CMOs;
• Facilitate and support analytical performance and efficiency improvements;
• Review and approve analytical documents e.g. laboratory investigations, validations, protocols, reports, and deviations;
• Support regulatory documentation, follow-up on post-approval commitments and answering regulatory questions on method- and stability related aspects to the authorities;
• Support our partners in different countries in preparing submission packages for the local authorities;
• Stay updated with scientific and regulatory development in areas of analytical testing, analytical methods, analytical validation, and stability testing;
• Contribute to establishing a strong QC organization within Ascendis Pharma.

Qualifications and Skills: 

• You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like;
• You have at least 8 years of experience from the pharmaceutical industry within chemical analysis, especially chromatographic methods (HPLC/UPLC, LC-MS, SE-HPLC), either from an Analytical Development Laboratory or from a QC Laboratory.

Furthermore, it is an advantage if you have experience with: 

• Collaboration and communication with external stakeholders enabling you to guide project teams at CMOs through conceptual as well as specific practical discussions;
• Management of stability programs, generation of protocols and reports, sample management and compilation of results.

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