(Senior) Project Manager/Process Specialist, Drug Substance Manufacturing

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 (Senior) Project Manager or Process Specialist.

• →Manage and coordinate outsourced commercial manufacture of peptides, 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 in collaboration with CMO’s including Deviation and Change management as subject matter expert
• →Support master batch record update and release of batches together with QA
• →Write and support regulatory submissions for marketing approval and post-approval

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:

• Relevant hands-on experience from laboratory, pilot and/or manufacturing facilities
• GMP experience
• Proficient English professional skills
• MS Office skills including experience with SAS JMP or other data management tools

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.

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. 

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.