Senior Design Control Specialist

Are you passionate about development of new drug-device combination products? Do you have experience within development of medical devices for drug delivery?

If so, now is your chance to join Ascendis Pharma as our new Senior Design Control 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 Senior Design Control Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in the development of new drug delivery solutions. 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 Development team, and report directly to the Head of Device Developmentwho is based in Hellerup. You will also be based in Hellerup.

Your key responsibilities will be:

• Development and design control of medical devices and combination products for drug delivery
• Preparation, review and maintenance of design control documentation including requirement management as well as verification, validation and design transfer documentation
• Development of packaging and labelling materials
• Coordination of design control activities with CMOs and consultants
• Preparation of regulatory submission documentation

Qualifications and Skills:

You hold a relevant academic degree – preferably a M.Sc. or Ph.D. of mechanical, biomedical or pharmaceutical engineering – and 5-10 years of experience within development of drug delivery solutions for drug-device combination products.

Furthermore, you have:

• Experience with medical device design control (according to relevant regulations and guidelines)
• Experience with packaging and labelling of medical devices
• Experience with preparation of regulatory submission documentation  
• Experience with CMO collaboration

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 have good communication skills and the ability to handle multiple tasks and opportunities simultaneously.

Travel: 10-20 days per year.

Office: Tuborg Boulevard 12, 2900 Hellerup, Denmark 

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 Thomas Ørts Pedersen, Vice President of Device Development (+45 24441154 or [email protected]) or visit out website www.ascendispharma.com