Organic Chemist/Process Specialist for Management of Outsourced Commercial API

Organic Chemist/Process Specialist for Management of Outsourced Commercial API

Ascendis Pharma

Hellerup, Denmark

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 CMO’s 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 CMO’s. A proven ability to communicate with stakeholders of other functions and disciplines is crucial.