QC Specialist with Project Manager skills

Are you passionate about bringing quality products to patients Do you have experience within QC processes and CMO handling

If so now is your chance to join Ascendis Pharma as one of our new QC Specialists.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking two passionate QC Specialists to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in CMO collaboration including Drive Tech Transfer of analysis between CMOs and keep QC oversight of our current and future CMOs. 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 joining the QC Chemistry team consisting of 8 colleagues and report directly to Dorte Søe Senior Director and Head of QC Chemistry who is based in Hellerup.

Your key responsibilities will be:

• Coordinate and keep oversight of analytical activities between Ascendis and CMOs
• Be the QC responsible for the Tech Transfer of tasks related to analysis to a new CMO and ensure establishing a good collaboration environment
• Facilitate and support analytical performance and efficiency improvements at CMOs and internally at Ascendis
• Writing of regulatory documentation and follow-up on post-approval commitments to authorities

Qualifications and Skills:

You hold a relevant academic degree preferably a Master of Science degree in Chemistry Engineering Pharmacy or the like and several years of experience within QC and the Pharmaceutical industry.

Furthermore you have:

• Deep understanding of the processes in a QC Laboratory supporting the chemical manufacturing either from a QC laboratory or an Analytical Development Laboratory
• Experience with Tech Transfer of analytical methods between different sites or companies including validation of analytical methods.
• Understanding of the complexity of not being directly involved in the laboratory work but work remotely with CMOs
• Experience working with GMP and relevant guidelines.
• Experience in supporting the Q&A process and Life Cycle Management of the regulatory files.

Key competencies:

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

You possess an entrepreneurial mindset and can thrive in an informal open environment where innovation and change are key.

To succeed in this role we also expect you to have an open and adaptive approach for collaboration within and outside the company. A structured and systematic mindset is an asset to keep overview even with many tasks and changes to priorities. A team mindset is essential and flexibility to new projects and priorities is needed to support each other within the team

Travel: 10-20 days per year.

Office: Ascendis Pharma resides in Tuborg Havn Hellerup

Apply now.

We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

To ensure your application is reviewed please submit it through the specified platform - applications sent by email or other channels will not be evaluated.

For more details about the position or the company please contact Dorte Søe Senior Director and Head of QC Chemistry

You can learn more about Ascendis by visiting our website

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Required Experience:

IC