Global Reference Standards Specialist

Ascendis Pharma; Hellerup; On-site; DKK 700,000 - 900,000; Full time

Job summary

Ascendis Pharma in Hellerup, Denmark, is seeking a Reference Standard Specialist to manage reference standards across CMOs and internal teams. You will work to ensure alignment with regulatory guidelines and maintain SOPs for continued compliance, logistics, and resupply.

The role involves coordinating with global colleagues, contributing to regulatory submissions, and supporting inspections as needed. A strong background in pharmaceutical sciences and HPLC is expected.

Qualifications

• Makes use of a master’s degree in pharmaceutical sciences or related field with at least 5 years in biotech/pharma focusing on reference standards.
• Experience coordinating reference standard activities and resupply for CMOs and internal teams.
• Knowledge of analytical sciences (chromatographic analyses, HPLC) and regulatory expectations for reference standards.

Responsibilities

• Coordinate establishment, maintenance, re-supply, recalibration and distribution of reference standards.
• Maintain overview of reference standards across development and commercial manufacturing, including storage, stock and expiry.
• Create internal SOPs and ensure updates align with external legislation and QMS requirements.
• Contribute to regulatory documents (IMPDs, INDs, NDAs, BLAs) and respond to authorities.

Skills

Structured approach

Collaboration

Communication

Attention to detail

Team player

High energy

Education

Master's degree in Pharmaceutical Sciences, Chemistry, Engineering or related field

Tools

HPLC

Job description

Ascendis Pharma in Hellerup, Denmark, is seeking a Reference Standard Specialist to manage reference standards across CMOs and internal teams. You will work to ensure alignment with regulatory guidelines and maintain SOPs for continued compliance, logistics, and resupply.

The role involves coordinating with global colleagues, contributing to regulatory submissions, and supporting inspections as needed. A strong background in pharmaceutical sciences and HPLC is expected.