Global Reference Standards Specialist (Cross-Functional)

Ascendis Pharma A/S; Gentofte Kommune; Remote; DKK 800,000 - 1,100,000; Full time

Job summary

Ascendis Pharma A/S is seeking a Reference Standard Specialist to manage activities with CMOs and internal QC teams. You will ensure alignment on reference standards, regulatory input, and inspection readiness, contributing to development and post-approval resupply alongside a global team.

You will work from our Hellerup HQ or collaborate with cross‑functional colleagues across Europe and the United States, driving continuous improvements in reference standard programs and regulatory compliance.

Qualifications

• Masters degree in Pharmaceutical Sciences, Chemistry, Engineering or related field.
• Minimum 5 years in biotech/pharma working with reference standards.
• Experience coordinating reference standard activities and resupply processes.

Responsibilities

• Plan, coordinate and document establishment, maintenance, re-supply, recalibration and distribution of reference standards and analytical substances.
• Maintain overview of reference standards across development and commercial manufacturing including storage, stock, stability and expiry.

Skills

Reference standards coordination

Project coordination

Analytical sciences

HPLC

Regulatory documentation

Education

Masters in Pharmaceutical Sciences

Chemistry

Tools

QMS systems

Job description

Ascendis Pharma A/S is seeking a Reference Standard Specialist to manage activities with CMOs and internal QC teams. You will ensure alignment on reference standards, regulatory input, and inspection readiness, contributing to development and post-approval resupply alongside a global team.

You will work from our Hellerup HQ or collaborate with cross‑functional colleagues across Europe and the United States, driving continuous improvements in reference standard programs and regulatory compliance.