Senior Professional, QA Commercial Drug Product & Finished Goods

Full Job Description

Are you passionate about Quality Assurance? Do you have experience working in the pharmaceutical industry?

If so, now is your chance to join Ascendis Pharma as our new Senior Professional, QA Commercial, Drug Product & Finished Goods.

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 portfolio. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Senior Professional to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in handling the daily operations such as batch review of drug product and finished goods, Quality records (Deviations, Change controls etc.) and collaboration with our internal and externals stakeholders (CMOs producing drug product and performing secondary packaging). 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 QA Commercial Drug Product & Finished Goods team consisting of 6 colleagues, and report directly to Nina Bornhøft Nielsen, Senior Director who is based in Hellerup office, Tuborg Boulevard 12. You will also be based in Hellerup.

We work with all aspects of quality oversight in relation to CMO production and your responsibilities will cover a broad range of tasks, documents, and assignments.

Your key responsibilities will be:

• Review of batch documentation
• Review of deviations, CAPAs and other relevant documentation
• Collaboration with internal and external stakeholders (CMOs)
• Support in planning and oversight of department tasks e.g. release
• Support departmental tasks, including SOP updates and APQR input

Qualifications and Skills:

You hold a master’s degree in natural science preferably MSc. Pharm. – and 2-5 years of experience within the pharmaceutical industry

Furthermore, you have:

• GMP knowledge
• Quality mindset - Critical thinking, pragmatic and yet with attention to the necessary details
• Cooperative and striving for smooth cooperation with many stakeholders.
• Experience with CMO collaboration
• Thrives in a multicultural, international and highly dynamic setting

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 be able to thrive in working with routine tasks with the opportunity to add on more complex assignments, be proficient in English at a professional level, both written and spoken, and you master MS Office.

Travel: Potentially 5-10 days per year.

Office: Tuborg Boulevard 12, 2900 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 Nina Bornhøft Nielsen, Senior Director, QA Commercial DP&FG, nbn@ascendispharma.com

You can learn more about Ascendis by visiting our website www.ascendispharma.com

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.

Qualifications And Requirements

Associate

Associate

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