Stability Coordinator

Are you passionate about data-handling Do you have experience within stability studies

If so now is your chance to join Ascendis Pharma as our new Stability Coordinator

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Stability Coordinator to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in supporting the stability SMEs by the administrative part of the stability studies. You will join the QC team and be part of the highly experienced and dedicated team consisting of 5 specialists. Among others the team has close collaboration with our colleagues in the drug product and device teams as well as development regulatory affairs and quality assurance. You will report directly to Senior Director Lars Bo Ekhart Jensen based in Hellerup.

Your key responsibilities will be:

• In collaboration with stability SME support initiation of stability studies with respective CMOs. This includes agreements budgeting administrative review of stability protocols and coordination within Ascendis Pharma to ensure timely initiation.
• Responsible for maintaining overview of stability studies and assuring timely reporting transfer of data and/or data review for further processing and shipment of samples between CMOs.
• Responsible for assuring that studies data and related documentation (e.g. CMO created deviations change controls protocols reports) are archived in Ascendis Quality and document system.
• Together with the SME maintain the overview and assure that data from the stability studies are in place in due time for critical deliveries such as submissions to health authorities.

Qualifications and Skills:

You are a trained laboratory technician or similar education and preferable at least 2 years of experience within similar job.

Furthermore you have experience with MS Excel.

Key competencies:

You are a strong team player analytical and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal open environment where innovation and change are key.

Success criteria in this role will be to establish and maintain a complete overview of all GMP stability studies initiated and timely assure data are available for further processing with an eye on critical deliveries. You will contribute actively within the project teams regarding stability studies. Additionally you will be an active player in establishing a close and high-standard collaboration with the CMOs that Ascendis Pharma works with and will be a value-adding resource to them.

Travel: 0-5 days per year.

Office: Tuborg Boulevard 12 2900 Hellerup Denmark

Apply now.

We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

To ensure your application is reviewed please submit it through the specified platform - applications sent by email or other channels will not be evaluated.

For more details about the position or the company please contact Senior Director Lars Bo Ekhart Jensen e-mail mobile number .

You can learn more about Ascendis by visiting our website

Applications must be submitted in English and will be treated confidentially.

Required Experience:

IC