Senior Specialist, CMC Drug Product Formulation Development

Are you passionate about drug product formulation development? Do you have extensive experience in pharmaceutical development from Biotech or Pharmaceutical industry?

If so, now is your chance to join Ascendis Pharma as our new senior specialist for CMC Drug Product Formulation Development.

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 Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in drug product formulation development together with your CMC colleagues and establishing a good collaboration with the CROs and CLOs used by Ascendis Pharma. 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 part of Pharmaceutical Development consisting of 12 employees and will report to the director of CMC Drug Product Formulation Development who is based in Hellerup, Denmark. You will be based in Hellerup, Denmark.

Your key responsibilities will be:

• Strategies for development of drug products and drug-device combination products.
• Conduct and report pharmaceutical development studies including formulation development and stability studies to support all clinical phases (requires knowledge with Design of Experiments and statistical analysis).
• Prepare specifications for drug products and drug-device combination products, including justification of test parameters, acceptance criteria and clinical qualification.
• Ensure compliance with external requirements, product quality, project timelines, budget, and facilitate product transfer from CMC to Product Supply.
• Write regulatory documentation, support interactions with Health Authorities, and report project progress to management.

Qualifications and Skills:

You hold a relevant academic degree – preferably a Master or PhD in Pharmacy, engineering, chemistry, or equal field – and 7+ years in Biotechnology or Pharmaceutical Development with 3+ years of direct experience with injectable formulation development.

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

To succeed in the role, we expect you to possess strong scientific leadership skills with the ability to balance risks and timelines across Ascendis project pipeline, and proactively handle multiple tasks and challenges simultaneously.

You possess good communication and stakeholder management skills when representing the drug product team in cross-functional and cross-site teams and with CROs and CLOs.

To thrive at Ascendis Pharma culture you possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

You possess a high energy level and are a highly motivated individual who enjoys working in a collaborative environment thriving with being in contact with new people.

Travel: 15-25 days per year.

Office: Denmark, Hellerup, Tuborg Boulevard 12

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 the director of Drug Product Formulation Development, Ellen Nagato Watanabe on +45 40 40 27 84 or [email protected], or visit our website www.ascendispharma.com.