Senior PM & Process Specialist, CMO Manufacturing

Ascendis Pharma; Gentofte Kommune; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Ascendis Pharma, headquartered in Hellerup, Denmark, seeks a Senior Project Manager or Process Specialist to lead outsourced commercial manufacture of peptides, starting materials, intermediates and APIs. The role includes tech transfer, PPQ, CPV, and collaboration with CMOs in a fast-paced, cross-functional environment.

You will drive process development, verification, and regulatory support, reporting to the Senior Director of Chemical Manufacturing.

Qualifications

• Master of Science or Ph.D. in organic chemistry, peptide synthesis, chemical engineering or equivalent; at least 5 years in pharmaceutical development or manufacturing.
• GMP experience required.
• Proficient English. MS Office skills including SAS JMP or other data management tools.
• Experience with technology transfer, PPQ, deviations or change management is a plus.

Responsibilities

• Manage outsourced commercial manufacture of peptides, starting materials, intermediates and APIs including tech transfer, PPQ, post-PPQ optimizations, risk management, control strategies and CPV.
• Troubleshooting with CMOs including deviation and change management.
• Support master batch record updates and batch releases with QA.
• Write and support regulatory submissions for marketing approval and post-approval.

Skills

Project management

Team collaboration

English proficiency

Analytical thinking

Quality mindset

Education

MSc or PhD in organic chemistry / peptide synthesis / chemical engineering

Tools

SAS JMP

MS Office

Job description

Ascendis Pharma, headquartered in Hellerup, Denmark, seeks a Senior Project Manager or Process Specialist to lead outsourced commercial manufacture of peptides, starting materials, intermediates and APIs. The role includes tech transfer, PPQ, CPV, and collaboration with CMOs in a fast-paced, cross-functional environment.

You will drive process development, verification, and regulatory support, reporting to the Senior Director of Chemical Manufacturing.