Senior Stability Specialist

Senior Stability Specialist

Ascendis Pharma

Hellerup, Denmark

We are seeking a passionate Senior Stability Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in establishing and maintaining oversight over stability studies conducted at our Contract Manufacturing Organizations (CMOs). This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams working together to achieve extraordinary results.

You will join the Drug Product QC team of four colleagues and report directly to Senior Director Lars Bo Ekhart Jensen, based in Hellerup.

Your key responsibilities will be:

• Establish and maintain oversight over stability studies on a product that is soon transferred from the development department.
• Coordination between Ascendis and CMOs of activities related to stability studies and analysis.
• 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.
• Writing and reviewing regulatory documentation and following up on post-approval commitments to authorities.
• Support authoring of regulatory stability sections and when needed, participate in response rounds with Health Authorities.
• 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, and you have at least 8 years of experience with stability studies from the pharmaceutical industry. It is an advantage if you have experience with analytical methods from either an Analytical Development Laboratory or a QC laboratory, as well as experience from working in a GMP environment.

Furthermore, you have experience with:

• Collaboration and communication with external stakeholders enabling you to guide project teams internally and 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.

Key personal competencies:

• You are a strong team player, analytical, and have a can-do attitude. Furthermore, you possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
• To succeed in this role, we also expect you to be structured and systematic in your approach to solving tasks. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive on being in contact with new people and you are proficient in English, both written and spoken.
• You know how to maintain a constructive working environment and are used to working with external stakeholders to support product supply programs to ensure that the stability activities are compliantly conducted and executed according to project timelines.
• You enjoy having a broad network and know how to secure an acceptable compliance level at CMOs with different approaches to GMP. You enjoy sharing knowledge and participating actively in projects and cross functional meetings. It is an advantage if you have experience working with CMOs.
• You are used to establishing overviews, preparing and following plans, and finding smarter ways of doing things are key goals for you.

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