Pharmaceutical Specialist
3 days ago
A highly skilled Senior Specialist is required to join our team at Ascendis Pharma. If you have experience in pharmaceutical development from biotech or pharmaceutical industry and are passionate about drug product formulation development, then this could be the ideal opportunity for you.
About Us:
Ascendis Pharma is a leading biopharmaceutical company with a focus on developing innovative treatments for patients worldwide. Our commitment to excellence and our dedication to delivering high-quality products has earned us a reputation as a trusted partner in the pharmaceutical industry.
Our Mission:
To deliver life-changing treatments that make a meaningful difference in patients' lives. We achieve this through our passion for science, our commitment to innovation, and our drive to push boundaries.
The Role:
We are seeking a highly skilled Senior Specialist to join our team. As a key member of the Ascendis Pharma team, you will play a crucial role in drug product formulation development and establish a good collaboration with the CROs and CMOs used by Ascendis Pharma.
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:
Drug Product Formulation Development:
- Developing and implementing strategies for the development of drug products and drug-device combination products.
- Conducting and reporting pharmaceutical development studies including formulation development and stability studies to support all clinical phases.
Regulatory Compliance:
- Ensuring compliance with external requirements, product quality, project timelines, and facilitating product transfer from CMC to Product Supply.
- Writing regulatory documentation, supporting interactions with Health Authorities, and reporting 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.
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 CMOs. 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.
Travel: 15-25 days per year.
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