Associate Principal Specialist - Injection Devices

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 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.
• Strong communication skills in English. Accurate writing is important since you will be responsible for technical files. When you communicate with colleagues in quality, regulatory and commercial functions, you have a high impact.
• You must thrive by setting clear direction for colleagues and suppliers. Project Management, Lean, people management, coaching or facilitation competencies will be an advantage in this position.

Key competencies:
You are a strong communicator and team player. You are 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, you must be persistent, pay a high level of attention to details and be goal orientated.

Travel: 5-10 days per year.

Office: Denmark, Tuborg Boulevard 12, 2900 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, Director, +4530626234 or visit out website www.ascendispharma.com

Hellerup