Organic ChemistProcess Specialist for Management of Outsourced Commercial API

Do you have experience with outsourced chemical manufacturing of starting materials intermediates and APIs Are you passionate about science-driven development and manufacturing support in collaboration with contract manufacturing organizations (CMOs)

If so now is your chance to join Ascendis Pharma as our new Specialist.

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 a skilled Organic Chemist/ Process Specialist to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in our team for commercial chemical manufacturing for projects having reached the stage of process qualification and commercial manufacturing. The manufacturing processes comprise classic organic chemistry peptide synthesis and peptide conjugation and purification. 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 Chemical Manufacturing team consisting of 6 colleagues and report directly to Birgitte M. Malle Senior Directorwho is based in Hellerup. You will be based in Hellerup.

Your key responsibilities will be:

• Manage and coordinate external commercial manufacture of chemical starting materials intermediates and APIs including technology transfer process validation (PPQ) post PPQ optimizations risk management control strategies and continuous process verification programs (CPV)
• Trouble shooting activities together with CMOs including Deviation and Change management as subject matter expert
• Support master batch record update and release of batches together with QA
• Writing of regulatory documentation for marketing approval and post-approval

Qualifications and Skills:

You hold a relevant academic degree preferably a Master of Science or a Ph.D. in organic chemistry peptide synthesis chemical engineering or equivalent and have at least 5 years of experience within pharmaceutical development or manufacturing industry.

Furthermore you have:

• GMP experience
• Proficient English professional skills
• MS Office skills including experience with SAS JMP or other data management tools

Key competencies:

You are a strong team player have attention to details 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 a highly motivated individual who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as your job is to establish and maintain good and productive collaboration with CMOs. A proven ability to communicate with stakeholders of other functions and disciplines is crucial.

Travel: up to 10-15 days per year.

Office: Tuborg Havn in Hellerup Denmark

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 Senior Director for Chemical Manufacturing Birgitte M. Malle

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