Principal Specialist, CMC Drug Product
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 Principal Specialist for CMC Drug Product.
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 Principal 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 directly to the VP of Pharmaceutical Development who is based in Hellerup, Denmark. You will be based in Hellerup.
Your key responsibilities will be:
- Scientific lead and subject matter expert for Aseptic Manufacturing and Sterile Fill-Finish activities during development and process validation.
- Cross-project technical lead
- Designing, executing, and reporting pharmaceutical development studies.
- 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 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 10+ years in Biotechnology or Pharmaceutical Development with 3+ years of direct experience with Injectable Formulation and Validation.
Furthermore, you have:
- Experience within the field of drug product manufacturing from the pharmaceutical with-in aseptic processes
- Advanced knowledge of cGMP requirements, regulations, and guidelines.Experience in Phase 3 and process validation manufacturing.
- Experience in formulation and/or process development and documentation, including regulatory and quality aspects of drug development projects.
You are a strong team player, analytical, and have a can-do attitude.
To succeed in the role, we expect you to possess strong project management skills with the ability to plan 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.
Travel: 15-25 days per year.
Office: Denmark, Hellerup, Tuborg Boulevard 12
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 email@example.com or visit out website www.ascendispharma.com