Scientist, CMC Drug Product Formulation Development

Scientist, CMC Drug Product Formulation Development

Ascendis Pharma

Hellerup, Denmark

Do you have experience in drug product development within the biotech or pharmaceutical industry? Are you passionate about pharmaceutical development studies, including stability testing and regulatory CMC documentation? If so, now is your chance to join Ascendis Pharma as our new Scientist for CMC Drug Product Formulation Development.

We are seeking a passionate Scientist to join our growing team. You will play a crucial role in drug product formulation development together with your CMC colleagues and establish 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 the Pharmaceutical Development team, which consists of 13 employees, and will report to the Director of CMC Drug Product Formulation Development, based in Hellerup, Denmark. Your position will also be based in Hellerup, Denmark.

Your key responsibilities will be:

• Support Specialists and Project Managers in achieving project goals;
• In collaboration with Specialists and Project Managers, plan and report drug product development studies including formulation development and stability studies to support all clinical phases (using Design of Experiments and statistical analysis);
• Write regulatory CMC documentation for clinical trials and market authorization applications;
• Write or provide input to specifications and justification of specifications for drug products and drug-device combination products;
• Ensure compliance with external requirements and product quality.

Qualifications and Skills:

You hold a relevant academic degree, preferably a Master or PhD in Pharmacy, Engineering, Chemistry, or equal field, and at least 2-3 years in Biotechnology or Pharmaceutical Development, with experience within injectable formulation development and/or regulatory affairs. Experience with a statistical tool e.g. SAS jmp would be beneficial.

Key competencies:

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

To succeed in the role, we expect you to possess strong scientific skills and proactively handle multiple tasks and challenges simultaneously. You possess good communication and stakeholder management skills when collaborating in cross-functional 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 changes are keys. 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.

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