Senior Specialist, CMC Drug Product Development

Ascendis Pharma

Hellerup, Denmark

Description:

Are you passionate about drug product development? Do you have extensive experience 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.

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 development together with your CMC colleagues and establishing a good collaboration with the CMOs 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 CMC Drug Product team consisting of 12 employees, and report to the leader of CMC Pharmaceutical Development who is based in Hellerup, Denmark. You will also be based in Hellerup.

Your key responsibilities will be:

Designing, executing, and reporting pharmaceutical development studies including formulation development and stability studies to support all clinical phases;
Knowledge and expertise with Design of Experiments study design and statistical analysis;
Expertise within aseptic Manufacturing and Sterile Fill-Finish activities during development, transfer and process validation;
Planning, executing, and reviewing drug product manufacturing campaigns and development studies together with CMOs and the project team (including QA);
Ensure that the drug product activities are conducted optimally with respect to quality, timelines, and budget;
Facilitate internal transfer of product and process responsibilities from CMC to Product Supply;
Writing regulatory quality documentation and support interactions with Health Authorities;
Report on project progress via line management and program review meetings.

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 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;
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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