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 Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.

Today, we are advancing programs in Endocrinology Rare Disease and Oncology. In addition, we collaborate with partners around the world on the development of TransCon-based products for 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, [email protected]

You can learn more about Ascendis by visiting our website www.ascendispharma.com

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.