Global Reference Standards Specialist — CMO Liaison

Ascendis Pharma; Herrested; Vor Ort; DKK 600.000 - 800.000; Vollzeit

Zusammenfassung

Ascendis Pharma seeks a Reference Standard Specialist to drive coordination with CMOs and internal QC teams. You will manage reference standards, regulatory support, and collaboration across global projects.

The role requires expertise in analytical methods and GMP/QMS alignment. You will report to the Associate Director for Reference Standards in Hellerup and work at the Denmark headquarters, engaging with cross-functional teams and external partners to ensure compliant and timely reference

Qualifikationen

• Master's degree in Pharmaceutical Sciences or related field with 5+ years in biotech/pharma reference standards.
• Experience coordinating reference standard activities and resupply.
• Knowledge of regulatory requirements for reference standards and GMP/QMS.

Aufgaben

• Plan, coordinate and document reference standard activities including distribution and recalibration.
• Maintain overview of reference standards across development and production phases.
• Create internal SOPs for reference standards and ensure updates to guidelines in QMS.
• Incorporate external regulatory updates into Ascendis Pharma documentation and processes.
• Contribute to regulatory documents (IMPD/IND/NDA/BLA) and assist inspection readiness of CMOs.

Kenntnisse

Collaboration & communication

Analytical skills

Team player

Organizational skills

Ausbildung

Master's degree in Pharmaceutical Sciences

Tools

HPLC

Bioassays

Jobbeschreibung

Ascendis Pharma seeks a Reference Standard Specialist to drive coordination with CMOs and internal QC teams. You will manage reference standards, regulatory support, and collaboration across global projects.

The role requires expertise in analytical methods and GMP/QMS alignment. You will report to the Associate Director for Reference Standards in Hellerup and work at the Denmark headquarters, engaging with cross-functional teams and external partners to ensure compliant and timely reference