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Ascendis Pharma, a global biopharmaceutical company, is seeking an experienced Project Manager or Process Specialist to join its Chemical Manufacturing team in Hellerup, Denmark. You will manage and coordinate outsourced commercial manufacturing of peptides, chemical starting materials, intermediates, and active pharmaceutical ingredients (APIs) for projects at the commercial manufacturing stage.
Key responsibilities include:
- Manage and coordinate outsourced commercial manufacture including technology transfer, process validation (PPQ), post-PPQ optimizations, risk management, control strategies, and continuous process verification programs (CPV)
- Troubleshoot in collaboration with contract manufacturing organizations (CMOs), serving as a subject matter expert for deviation and change management
- Support master batch record updates and batch release in coordination with Quality Assurance
- Write and support regulatory submissions for marketing approval and post-approval activities
You will report directly to the Senior Director of Chemical Manufacturing and work within a team of 6 colleagues. The role involves collaboration with cross-functional, global teams and requires travel of up to 10-15 days per year. The manufacturing processes encompass peptide synthesis, peptide conjugation and purification, and classic organic chemistry for small molecules and polymers.
This is an opportunity to work in a fast-paced, science-driven environment at a company advancing programs in endocrinology rare disease and oncology portfolios using its proprietary TransCon® technology platform.
Qualifications and Requirements:
- Master of Science or Ph.D. in organic chemistry, peptide synthesis, chemical engineering, or equivalent
- Minimum 5 years of experience in pharmaceutical development or manufacturing industry
- Relevant hands-on experience from laboratory, pilot, and/or manufacturing facilities
- GMP (Good Manufacturing Practice) experience
- Proficient English professional skills
- MS Office skills including experience with SAS JMP or other data management tools
- Strong team player with attention to detail and can-do attitude
- Entrepreneurial mindset and ability to thrive in informal, open environments
- Excellent interpersonal and communication skills with ability to collaborate across functions and with external CMO partners
