Reference Standard Specialist

About the role

Ascendis Pharma seeks a Reference Standard Specialist to act as the primary liaison between the company and Contract Manufacturing Organizations (CMOs) on reference standard matters. You will ensure smooth coordination of analytical testing, regulatory compliance, and supply of reference standards across development and commercial phases.

Key responsibilities

• Plan, coordinate and document activities for establishment, maintenance, re‑supply, recalibration and distribution of reference standards and critical analytical substances.
• Maintain an overview of reference standards for all product phases, including storage locations, stock levels, stability and expiry dates.
• Develop and update internal guidance (SOPs) and ensure external legislation and guidelines are reflected in the QMS.
• Contribute as an author to regulatory documents (IMPD, IND, NDA, BLA) and support inspections and CMO readiness assessments.

Required profile

• Master’s degree in Pharmaceutical Sciences, Chemistry, Engineering or related field.
• Minimum 5 years of experience in biotech or pharmaceutical industry working with reference standards.
• Proven ability to guide project teams at CMOs through both conceptual and practical discussions.
• Strong collaboration, communication and organizational skills with a detail‑oriented, can‑do attitude.

Required skills

• Experience with HPLC and other chromatographic analyses.
• Knowledge of bioassays for large molecules, polymers, proteins or peptides.
• Familiarity with regulatory requirements for reference standards and preparation of related documentation.