Global Reference Standards Specialist - CMO Partnerships

Ascendis Pharma; Gentofte Kommune; Vor Ort; DKK 700.000 - 900.000; Vollzeit

Zusammenfassung

Ascendis Pharma is seeking a dedicated Reference Standard Specialist to join the Reference Standards team at our Hellerup headquarters. You will liaise between Ascendis and CMOs, ensuring alignment on reference standards, testing, and regulatory expectations across development and commercial phases.

The role involves authoring regulatory documents, updating the QMS with new standards, and collaborating with global teams. Travel up to 10 days/year is expected.

Qualifikationen

• Minimum 5 years in biotech/pharma with reference standards.
• Experience guiding CMOs through project discussions and coordination.
• Knowledge of chromatographic analyses (HPLC) and bioassays is advantageous.

Aufgaben

• Plan, coordinate and document reference standards activities (establishment, maintenance, recalibration, distribution).
• Maintain overview of reference standards across development and manufacturing, including storage, stock, expiry.
• Create internal guidance for reference standards (SOPs/guides).
• Update external legislation and guidelines in Ascendis Pharma QMS.
• Contribute to regulatory documents (IMPDs, INDs, NDAs, BLAs) and respond to authorities.
• Support inspector readiness and assess CMO readiness.

Kenntnisse

Reference standards

Coordination

HPLC

Regulatory docs

Cross-functional

Analytical testing

Communication

Ausbildung

Master's in Pharmaceutical Sciences

Tools

QMS system

Regulatory databases

Jobbeschreibung

Ascendis Pharma is seeking a dedicated Reference Standard Specialist to join the Reference Standards team at our Hellerup headquarters. You will liaise between Ascendis and CMOs, ensuring alignment on reference standards, testing, and regulatory expectations across development and commercial phases.

The role involves authoring regulatory documents, updating the QMS with new standards, and collaborating with global teams. Travel up to 10 days/year is expected.