Associate Director - 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 biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

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.

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.