Senior Project Manager & Process Specialist, Pharma CMO

Ascendis Pharma; Gentofte Kommune; Vor Ort; DKK 900.000 - 1.200.000; Vollzeit

Zusammenfassung

Ascendis Pharma is seeking a skilled Senior Project Manager or Process Specialist to lead outsourced chemical manufacturing programs for peptides, intermediates and APIs. The role covers tech transfer, PPQ, process verification, risk management and change control in a fast-paced environment at the Hellerup site.

You will collaborate cross-functionally with global teams, ensure GMP compliance, and support regulatory submissions.

Qualifikationen

• Master of Science or PhD in organic chemistry, peptide synthesis, chemical engineering or equivalent.
• At least 5 years of experience in pharmaceutical development or manufacturing.
• GMP experience and proficiency in data tools are required.

Aufgaben

• Manage outsourced commercial manufacture of peptides, starting materials, intermediates and APIs.
• Coordinate technology transfer, PPQ, CPV and continuous process verification programs.
• Trouble shooting with CMOs, including deviation and change management.
• Support master batch record updates and batch release with QA.

Kenntnisse

Team player

GMP experience

English proficiency

Ausbildung

Master of Science or PhD in organic chemistry/peptide synthesis/chemical engineering

Tools

SAS JMP

MS Office

Jobbeschreibung

Ascendis Pharma is seeking a skilled Senior Project Manager or Process Specialist to lead outsourced chemical manufacturing programs for peptides, intermediates and APIs. The role covers tech transfer, PPQ, process verification, risk management and change control in a fast-paced environment at the Hellerup site.

You will collaborate cross-functionally with global teams, ensure GMP compliance, and support regulatory submissions.