Formulation Development Expert for Pharmaceutical Innovation

21 hours ago


Gentofte, Gentofte Kommune, Denmark Ascendis Pharma Full time

About Ascendis Pharma

Ascendis Pharma is a fast-growing biopharmaceutical company dedicated to 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 develop new and potentially best-in-class therapies to address unmet medical needs.

We are seeking an experienced Senior Specialist, CMC Drug Product Formulation Development 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 good collaboration with external partners.

About the Role

You will be part of a talented team within Pharmaceutical Development, reporting to the director of CMC Drug Product Formulation Development based in Hellerup, Denmark. Your responsibilities will include:

  • Development Strategies: Develop strategies for drug products and drug-device combination products
  • Pharmaceutical Development Studies: Conduct and report pharmaceutical development studies, including formulation development and stability studies, to support all clinical phases
  • Specifications Preparation: Prepare specifications for drug products and drug-device combination products, including justification of test parameters, acceptance criteria, and clinical qualification
  • Compliance and Project Management: Ensure compliance with external requirements, product quality, project timelines, and facilitate product transfer from CMC to Product Supply
  • Regulatory Documentation: Write regulatory documentation and support interactions with Health Authorities

Requirements and Qualifications

To succeed in this role, you will need:

  • A relevant academic degree (Master or PhD) in Pharmacy, Engineering, Chemistry, or equal field
  • 7+ years of experience in Biotechnology or Pharmaceutical Development, with 3+ years of direct experience with injectable formulation development
  • Strong scientific leadership skills, analytical thinking, and a can-do attitude
  • Excellent communication and stakeholder management skills

About You

We are looking for a strong team player who can thrive in our informal, open environment where innovation and change are key. If you have a passion for drug product formulation development and are eager to take on new challenges, we encourage you to apply.



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