Associate Principal Specialist - Device Manufacturing

Are you passionate about medical devices Do you know how to prepare drug-device combination products for new market Will you be the one setting direction for life cycle management activities

If so now is your chance to join Ascendis Pharma as our new Associate Principal Specialist.

Ascendis Pharmais 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 and result orientated specialist to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in industrialization and globalization of our products. This is an exciting opportunity to work in a fast-paced environment collaborate with cross-functional global teams working together to achieve extraordinary results.

You will be joining the Device Manufacturing team consisting of four colleagues and report directly to Senior Director of Device Manufacturing.

Your key responsibilities will be:

• Prepare devices and drug-device combination products for new markets together with Regulatory Affairs Device Development specialists Supply Chain Operations and Quality Assurance.
• Establish plans and coordinate device related activities within globalization and life cycle management. Drive industrialization and improvement projects.
• Collaborate closely with product maintenance managers at our suppliers. Negotiate project offers from suppliers and oversee project cost and progress.
• Act as a specialist for marketed products and share your product knowledge whenever needed.
• Manage changes deviations and input to complaints.

Qualifications and Skills:

You hold a relevant technical degree and ten years of experience within medical device or pharmaceutical industry.

Furthermore you have:

• Experience within injection devices as well as EU and US regulation of medical devices and drug-device combination products.
• Experience within change control deviation management and product quality complaints.
• Experience with maintenance of Design History File and Device Master Record. Experience as a Risk Manager is a plus.

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.

To succeed in this role we also expect you to be a strong communicator and result orientated.

Travel: 5-10 days per year.

Office: Denmark Hellerup

Apply now.

Applications will be evaluated when received so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

For more details about the position or the company please contact Lasse Christoffersen Sr. Director of Device Manufacturing

You can learn more about Ascendis by visiting our website

Applications submitted via email or other channels will not be reviewed.

Please note: Due to the summer holiday period our response times may be a bit longer than usual. We appreciate your patience and look forward to reviewing your application as soon as possible.